Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants

Browse trials for

• Asphyxia Neonatorum 106
• Hyperoxia 115
• Respiratory Insufficiency 1,369

Keywords

• Delayed Cord Clamping
• IVH- Intraventricular Hemorrhage
• Hyperoxia in Neonates
• Hypoxia Neonatal
• Continuous Positive Airway Pressure (CPAP)

Asphyxia Neonatorum

106 studies on the registry are indexed under Asphyxia Neonatorum; 19 are open to participants now.

This study's enrollment of 140 is below the median of 173 across 73 interventional studies indexed under Asphyxia Neonatorum.

Lead sponsor

Sharp HealthCare is the lead sponsor of 40 studies on the registry; 4 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Study arms

• Active comparator
  DCC and Low Oxygen Concentration

  During 90 seconds of delayed cord clamping, the infant will receive gentle stimulation and start CPAP by 30 seconds of life at an FiO2 .30, with CPAP of 5 cmH20. If the infant is apneic or there is no Pedicap color change the team will begin positive pressure ventilation (starting PIP of 20 cmH20) by 60 seconds of life. The infant will remain on this support up until the umbilical cord is clamped at 90 seconds or greater. Once the cord is clamped the infant resuscitation will continue according to unit protocol.

  Procedure: Delayed Cord Clamping with Low Oxygen concentration

• Experimental
  DCC and High Oxygen Concentration

  During 90 seconds of delayed cord clamping, the infant will receive gentle stimulation and start CPAP by 30 seconds of life at an FiO2 1.0, with CPAP of 5 cmH20. If the infant is apneic or there is no Pedicap color change the team will begin positive pressure ventilation (starting PIP of 20 cmH20) by 60 seconds of life. The infant will remain on this support up until the umbilical cord is clamped at 90 seconds or greater. Once the cord is clamped the infant resuscitation will continue according to unit protocol.

  Procedure: Delayed Cord Clamping with High Oxygen concentration

Interventions

• ProcedureDelayed Cord Clamping with Low Oxygen concentration

  During delayed umbilical cord clamping of 90 seconds, breathing assistance with CPAP/PPV and low oxygen concentration (FiO2 0.30) will be provided.

  Also known as: DCC with Low Oxygen concentration, DCC LO group

• ProcedureDelayed Cord Clamping with High Oxygen concentration

  During delayed umbilical cord clamping of 90 seconds, breathing assistance with CPAP/PPV and high oxygen concentration (FiO2 1.0) will be provided.

  Also known as: DCC with High Oxygen concentration, DCC HI group

Primary outcomes

1. Number of Participants Achieving a Peripheral Oxygen Saturation of 80 Percent by 5 Minutes After Birth

   Indicates whether enrolled infants achieved a preductal peripheral oxygen saturation (SpO₂) of at least 80% by 5 minutes after birth. Preductal SpO₂ was measured using pulse oximetry, with the probe placed on the infant's right hand, in accordance with standard neonatal resuscitation practices. Following completion of the deferred cord-clamping period and clamping and cutting of the umbilical cord, SpO₂ monitoring was initiated during delivery room resuscitative care.The assessment time point was defined as 5 minutes after delivery. When continuous SpO₂ monitoring tracings were available, these data were reviewed to determine whether the infant achieved a preductal SpO₂ of at least 80% by the 5-minute time point. When continuous tracings were not available, contemporaneous nursing documentation was reviewed in a blinded manner to determine whether the SpO₂ threshold was achieved. The outcome was analyzed as a dichotomous measure (SpO₂ ≥80% vs \<80%) using an intention-to-treat approach

   Time frame: Assessed during the period from arrival at the Panda bed warmer for initial resuscitation until 5 minutes after birth.

Secondary outcomes

1. Any Intraventricular Hemorrhage (Grades 1-4)

   Presence of any intraventricular hemorrhage (IVH), defined as Grade 1 through Grade 4, as diagnosed by cranial ultrasound performed according to routine neonatal care practices. IVH grading followed standard neonatal neuroimaging criteria, and results were abstracted from clinical radiology reports.

   Time frame: From birth to initial neonatal intensive care unit discharge, up to 6 months corrected age

2. Grade III and IV Intraventricular Hemorrhage

   Proportion of participants with severe intraventricular hemorrhage (Grades 3-4), defined as Grade 3 intraventricular hemorrhage with ventricular dilation or Grade 4 intraventricular hemorrhage with extension into the brain parenchyma, as classified according to the Papile grading system, assessed by cranial ultrasound.

   Time frame: Birth to initial neonatal intensive care unit discharge, up to 6 months corrected age

3. Mean Heart Rate (BPM) in the First 10 Minutes of Life

   Mean heart rate, expressed in beats per minute (BPM), of participants during the first 10 minutes of life. Heart rate is assessed in accordance with standard neonatal resuscitation monitoring practices using continuous electrocardiographic (ECG) monitoring or pulse oximetry, when available, or by auscultation or palpation if electronic monitoring is not feasible. Heart rate values obtained during the immediate post-birth period are recorded at regular intervals or continuously, and the outcome is reported as the mean BPM for each newborn across the first 10 minutes of life.

   Time frame: Assessed during the period from arrival at the Panda bed warmer for initial resuscitation until 10 minutes after birth.

4. Resuscitation Interventions: Endotracheal Intubation

   Number of participants who undergo endotracheal intubation during neonatal resuscitation immediately following delivery. Intubation is defined as the placement of an endotracheal tube into the infant's trachea by a trained provider as part of resuscitative care in the delivery room. The outcome is recorded for each newborn during the immediate post-birth period and reported as the total number of infants requiring intubation.

   Time frame: From birth up to 30 minutes after birth

5. Resuscitation Interventions: Administration of Exogenous Surfactant

   Number of participants who receive administration of exogenous surfactant during neonatal resuscitation immediately following birth. Administration of surfactant is defined, per Neonatal Resuscitation Program (NRP) guidelines, as the delivery of exogenous surfactant to the newborn, typically via an endotracheal tube, as part of advanced delivery room respiratory support. The outcome is assessed for each newborn during the immediate post-birth resuscitation period and reported as the total number of infants who receive exogenous surfactant.

   Time frame: From birth up to 30 minutes after birth.

6. Resuscitation Intervention: Chest Compressions

   Number of participants who receive chest compressions during neonatal resuscitation immediately following birth. Chest compressions are defined, per Neonatal Resuscitation Program (NRP) guidelines, as coordinated cardiac compressions as part of advanced resuscitative care in the delivery room. The outcome is assessed for each newborn during the immediate post-birth resuscitation period and reported as the total number of infants who receive chest compressions.

   Time frame: Birth up to 30 minutes after birth

7. Resuscitation Intervention: Epinephrine Administration

   Number of participants who receive epinephrine administration during neonatal resuscitation immediately following birth. Epinephrine administration is defined, per Neonatal Resuscitation Program (NRP) guidelines, as the delivery of epinephrine via an approved route (intravenous, intraosseous, or endotracheal) as part of advanced resuscitative care in the delivery room. The outcome is assessed for each newborn during the immediate post-birth resuscitation period and reported as the total number of infants who receive epinephrine.

   Time frame: Assessed during the period from arrival at the Panda bed warmer for initial resuscitation until 30 minutes after birth.

Other outcomes

1. Inspired Fractional Oxygen (FiO2)

   Fraction of inspired oxygen (FiO₂) administered to participants during neonatal care in the immediate post-birth period. Inspired fractional oxygen is defined as the concentration of oxygen delivered to the newborn via respiratory support devices, including free-flow oxygen, continuous positive airway pressure (CPAP), or positive pressure ventilation, in accordance with Neonatal Resuscitation Program (NRP) guidelines. FiO₂ values are recorded continuously during the first 10 minutes of life, and the outcome is reported as the median FiO₂ administered to each newborn during this period.

   Time frame: Assessed during the period from arrival at the Panda bed warmer for initial resuscitation until 10 minutes after birth.

2. Duration of Hypoxia

   Duration of hypoxia during the immediate post-birth period, defined as the cumulative time an infant's oxygen saturation (SpO₂) remains below the 25th percentile of the minute-by-minute, gestational-age-specific reference ranges described by Dawson et al. Oxygen saturation is continuously monitored using preductal pulse oximetry during the first 10 minutes of life. For each minute of life, observed SpO₂ values are compared with the corresponding reference threshold for extremely preterm infants, and hypoxia is identified when SpO₂ falls below the defined percentile for that minute. The outcome is calculated for each newborn as the total duration of time spent below the target oxygen saturation range during the first 10 minutes of life, based on measurements obtained after cord clamping and transfer to the Panda bed warmer for initial resuscitation.

   Time frame: Assessed during the period from arrival at the Panda bed warmer for initial resuscitation until 10 minutes after birth.

3. Duration of Hyperoxia

   Duration of hyperoxia during the immediate post-birth period, defined as the cumulative time an infant's oxygen saturation (SpO₂) exceeds the upper reference limits expected for minute-specific postnatal transition, as described by Dawson et al. Oxygen saturation is continuously monitored using preductal pulse oximetry during the first 10 minutes of life. SpO₂ values are evaluated relative to gestational-age-specific reference ranges, and hyperoxia is identified when saturation exceeds levels typically observed once physiologic transition is achieved in extremely preterm infants (generally approaching or exceeding \~90-94% in the later minutes of life).The outcome is calculated for each newborn as the total duration of time spent above the target oxygen saturation range during the first 10 minutes of life, based on mThe outcome is calculated for each newborn as the total duration of time spent above the defined oxygen saturation threshold during the first 10 minutes following delivery.

   Time frame: Assessed during the period from arrival at the Panda bed warmer for initial resuscitation until 10 minutes after birth.

4. Mean Airway Pressure, MAP (cm H₂O)

   The mean airway pressure (MAP), expressed in centimeters of water (cm H₂O), delivered to participants during neonatal respiratory support in the immediate post-birth period. Defined as the average pressure applied to the airways throughout the respiratory cycle during assisted ventilation modalities, including positive pressure ventilation and continuous positive airway pressure (CPAP). MAP is continuously monitored or derived from ventilator settings during the first 10 minutes of life. The outcome is calculated for each newborn as the mean MAP value recorded during this period.

   Time frame: Assessed during the period from arrival at the Panda bed warmer for initial resuscitation until 10 minutes after birth.

5. Duration of Positive Pressure Ventilation

   Duration of positive pressure ventilation (PPV) administered to participants during neonatal resuscitation in the immediate post-birth period. The duration of PPV is recorded from the initiation of assisted breaths until cessation of positive pressure support during delivery room resuscitation. The duration of PPV is calculated beginning after the umbilical cord is clamped and cut and is recorded during the first 10 minutes after delivery. The outcome is calculated for each newborn as the total cumulative duration of time, reported in seconds, receiving positive pressure ventilation during this period.

   Time frame: Assessed during the period from arrival at the Panda bed warmer for initial resuscitation until 10 minutes after birth.

6. Mean Blood Pressure

   Blood pressure was assessed using noninvasive cuff measurements or invasive arterial monitoring, when available, in accordance with standard neonatal clinical practice. Measurements obtained at approximately hourly intervals from birth through 24 hours of age were recorded for each infant. The outcome is reported as the mean blood pressure, calculated as the average of all available blood pressure measurements obtained during the first 24 hours of life.

   Time frame: From neonatal intensive care unit admission to the first 24 hours of life

7. Cerebral Tissue Oxygenation

   Measures cerebral tissue oxygenation during the early postnatal period from stabilization following initial resuscitation through 24 hours after birth. Cerebral tissue oxygenation is assessed using near-infrared spectroscopy (NIRS), with sensors placed on the frontoparietal region of the scalp in accordance with standard neonatal monitoring practices to noninvasively measure regional cerebral oxygen saturation (StO₂). Monitoring may be initiated as early as placement on the Panda bed warmer for initial resuscitation. When monitoring cannot be initiated during resuscitation, NIRS monitoring begins following stabilization or at the time of admission to the neonatal intensive care unit. Cerebral tissue oxygenation is recorded continuously through 24 hours after birth. For reporting purposes, cerebral tissue oxygenation is summarized for each participant as the time-weighted mean StO₂, expressed as a percentage (%), calculated over the monitoring period through 24 hours after birth.

   Time frame: Assessed continuously from arrival at the Panda bed warmer for initial resuscitation up to 24 hours after birth.

8. Oxygen Saturation

   Measures peripheral arterial oxygen saturation (SpO₂) in participants during neonatal resuscitation in the delivery room. Peripheral oxygen saturation is assessed using standard pulse oximetry (preductal placement) in accordance with routine neonatal monitoring practices. For all participants, monitoring is initiated immediately after umbilical cord clamping during delivery room resuscitative care. Continuous SpO₂ measurements are recorded and summarized into 1 minute intervals; minute level values represent the arithmetic mean of all valid measurements recorded within each minute. The assessment window is defined as the first 5 minutes of life following birth. For reporting purposes, SpO₂ is summarized for each newborn as the arithmetic mean of the available 1 minute mean values across this 5 minute period, expressed as a percentage (%). Participants with incomplete data contribute available minute level data within the defined time window.

   Time frame: Assessed continuously from arrival at the Panda bed warmer for initial resuscitation through 5 minutes after delivery.

9. Average Heart Rate

   Measures heart rate in participants during neonatal resuscitation in the delivery room. Heart rate is measured using continuous electrocardiography (ECG) as part of routine neonatal monitoring. If ECG heart rate measurements are not available, heart rate derived from pulse oximetry is used instead. For all participants, monitoring begins immediately after umbilical cord clamping during delivery room resuscitative care. Heart rate data are recorded continuously and summarized into 1-minute intervals. Each minute-level value represents the average of all valid heart rate measurements recorded during that minute. The assessment period is the first 5 minutes after birth. For reporting purposes, heart rate is summarized for each newborn as the average of the available minute-level values across this 5-minute period and is expressed in beats per minute (bpm). Participants with incomplete data contribute all available measurements within the assessment period.

   Time frame: Assessed continuously from arrival at the Panda bed warmer for initial resuscitation through 5 minutes after delivery.

10. Intubation in the Delivery Room or Neonatal Intensive Care Unit (NICU)

    Measures number of infant underwent endotracheal intubation at any time during delivery room resuscitation or during the subsequent neonatal intensive care unit (NICU) hospitalization. Intubation events were identified from clinical records and reflect standard clinical care. For reporting purposes, the outcome was defined as the occurrence of at least one endotracheal intubation during the assessment period and was analyzed as a dichotomous outcome (intubated vs not intubated).).

    Time frame: From birth to initial neonatal intensive care unit discharge, up to 6 months corrected age

11. Highest Hemoglobin

    Measures the highest hemoglobin level recorded for each participant prior to any red blood cell transfusion during the neonatal intensive care unit (NICU) hospitalization. Hemoglobin values were obtained from clinically indicated blood samples as part of routine care. For reporting purposes, the outcome was defined as the maximum hemoglobin concentration measured before the first transfusion, expressed in grams per deciliter (g/dL).

    Time frame: Birth up to 24 hours after delivery

12. Lowest Hemoglobin

    This outcome measures the lowest hemoglobin level recorded for each participant prior to any red blood cell transfusion during the neonatal intensive care unit (NICU) hospitalization. Hemoglobin values were obtained from clinically indicated blood samples as part of routine care. For reporting purposes, the outcome was defined as the minimum hemoglobin concentration measured before the first 24 hours after delivery and before transfusion.

    Time frame: Birth up to 24 hours after delivery

13. Highest Hematocrit

    This outcome measures the highest hematocrit value recorded for each participant prior to any red blood cell transfusion during the neonatal intensive care unit (NICU) hospitalization. Hematocrit values were obtained from clinically indicated blood samples as part of routine care. For reporting purposes, the outcome was defined as the maximum hematocrit percentage measured before the first transfusion, expressed as a percentage (%).

    Time frame: Birth up to 24 hours of age or until blood transfusion, whichever occurred first

14. Lowest Hematocrit

    This outcome measures the lowest hematocrit value recorded for each participant prior to any red blood cell transfusion during the neonatal intensive care unit (NICU) hospitalization. Hematocrit values were obtained from clinically indicated blood samples as part of routine care. For reporting purposes, the outcome was defined as the minimum hematocrit percentage measured before the first transfusion, expressed as a percentage (%).

    Time frame: Birth up to 24 hours of age or until blood transfusion, whichever occurred first

15. Steroids for Blood Pressure Support

    Measures whether participants received systemic corticosteroids for treatment of hypotension requiring blood pressure support during the neonatal intensive care unit (NICU) hospitalization. Steroid administration was determined by the clinical care team in accordance with standard neonatal practice. For reporting purposes, the outcome was defined as the occurrence of steroid use for blood pressure support in the first 24 hours after delivery and was analyzed as a dichotomous outcome (received steroids vs did not receive steroids).

    Time frame: From neonatal intensive care unit admission up to 24 hours of age

16. Clinical Risk Index for Babies II (CRIB-II)

    The Clinical Risk Index for Babies II (CRIB-II) is a validated illness-severity scoring system used to assess the initial risk of mortality in preterm infants. The CRIB-II score is calculated using clinical variables collected within the first 12 hours after birth, including gestational age, birth weight, admission temperature, and sex. CRIB-II scores range from 0 to 27, with higher scores indicating greater illness severity and higher predicted risk of mortality, and lower scores indicating lower clinical risk. The outcome is reported as the mean CRIB-II score across all eligible participants.

    Time frame: From birth up to 12 hours after delivery

17. Number of Days on Mechanical Ventilation

    The duration of respiratory support was calculated for each participant as the total number of days during which the infant received invasive mechanical ventilation. Any calendar day on which mechanical ventilation was administered was counted as one day of respiratory support, regardless of the duration within that day. The outcome is summarized as the median number of days of respiratory support across participants.

    Time frame: Birth to initial neonatal intensive care unit discharge, up to 6 months corrected age

18. Number of Days Receiving CPAP and/or Non-Invasive Mechanical Ventilation

    The duration of respiratory support was calculated for each participant as the total number of days during which the infant received non-invasive respiratory support, including continuous positive airway pressure (CPAP) and/or non-invasive mechanical ventilation (NIMV). Any calendar day on which CPAP or NIMV was administered was counted as one day of respiratory support, regardless of the duration within that day. The outcome is summarized as the median number of days of respiratory support across participants.

    Time frame: From initial neonatal intensive care unit admission to initial neonatal intensive care unit discharge, up to 6 months corrected age

19. Surfactant Administration

    Surfactant administration was defined as the receipt of any exogenous pulmonary surfactant from enrollment to initial NICU admission discharge. This outcome captured whether surfactant was administered at any time, regardless of the specific preparation, dose, route of administration, or need for repeat dosing. Administration was determined from medical record documentation.

    Time frame: From birth to initial neonatal intensive care unit discharge, up to 6 months corrected age

20. Number of Packed Red Blood Cell (pRBC Transfusions

    The number of packed red blood cell (pRBC) transfusions administered during the first 10 days after delivery was recorded for each participant. This outcome measured the total count of discrete pRBC transfusion events received within this period, regardless of transfusion volume, indication, or timing within the 10-day window. Transfusion events were ascertained from medical record documentation and summarized across participants using the median number of transfusions with interquartile range (IQR).

    Time frame: Birth up to 10 days after delivery

21. Patent Ductus Arteriosus Requiring Pharmacological or Surgical Treatment

    The occurrence of a patent ductus arteriosus (PDA) that required active treatment any time during initial NICU admission. PDA was considered to meet this outcome if pharmacological therapy and/or surgical or catheter-based ligation was initiated. Participants were counted once if any qualifying treatment for PDA was administered, regardless of the number of treatment courses or type of intervention. Treatment status was determined from medical record documentation and summarized as the number and proportion of participants requiring pharmacological or surgical PDA treatment.

    Time frame: Through study completion at discharge, up to 6 months of corrected age

22. Spontaneous Intestinal Perforation (SIP) Requiring Surgery or Peritoneal Drain

    Occurrence of spontaneous intestinal perforation (SIP) that required invasive intervention during the study period. SIP was considered to meet this outcome if the participant required surgical management (e.g., laparotomy) and/or placement of a peritoneal drain. Participants were counted once if any qualifying surgical or drainage intervention for SIP occurred, regardless of subsequent procedures. Occurrence was determined through medical record documentation and summarized as the number and proportion of participants with SIP requiring surgery or peritoneal drainage.

    Time frame: Through study completion at discharge, up to 6 months of corrected gestational age

23. Necrotizing Enterocolitis (Modified Bell's Stage 2-3)

    Occurrence of necrotizing enterocolitis (NEC) classified as Modified Bell's stage 2 or stage 3 during the study period. NEC was considered to meet this outcome if clinical, radiographic, and/or surgical findings were consistent with Bell's stage II (definite NEC) or stage III (advanced NEC), as documented in the medical record. Participants were counted once if they met criteria for stage 2 or 3 NEC at any time, regardless of progression, recurrence, or need for surgical intervention. Occurrence was determined through review of clinical documentation and summarized as the number and proportion of participants diagnosed with stage 2-3 NEC.

    Time frame: birth to initial neonatal intensive care unit to discharge up to 6 months of age

24. Bronchopulmonary Dysplasia Grade 2-3

    Occurrence of moderate to severe bronchopulmonary dysplasia (BPD Grade 2-3) at 36 weeks postmenstrual age (PMA), as defined by Jensen, Dysart, Gantz, et al. BPD Grade 2-3 was defined by the requirement for noninvasive respiratory support (e.g., continuous positive airway pressure or noninvasive ventilation) or invasive mechanical ventilation at 36 weeks PMA, regardless of prior oxygen exposure or clinical course. Participants were classified based on the highest level of respiratory support administered at 36 weeks PMA. Each participant was counted once if criteria for BPD Grade 2 or Grade 3 were met. Classification was determined through review of medical record documentation and summarized as the number and proportion of participants with BPD Grade 2-3.

    Time frame: birth until 36 weeks postmenstrual age

25. Severe ROP (Stage 3 or Treated With Laser or Bevacizumab)

    Severe retinopathy of prematurity (ROP) was defined as Stage 3 or Stage 4 ROP, or ROP requiring treatment, including laser photocoagulation surgery and/or intravitreal anti-vascular endothelial growth factor (VEGF) therapy (e.g., bevacizumab \[Avastin\]), in either eye. ROP stage and treatment status were determined based on standardized ophthalmologic examinations performed by qualified ophthalmologists according to established international classification criteria. Participants meeting any of these criteria were classified as having severe ROP requiring treatment.

    Time frame: After the intervention through study completion at hospital discharge, up to 6 months of corrected gestational age

26. Combined Outcome of Severe IVH and/or Death

    Defined as the occurrence of severe intraventricular hemorrhage (IVH) and/or death. Severe IVH was defined as Grade III or Grade IV IVH according to the Papile classification, as determined by cranial ultrasound performed as part of routine clinical care and interpreted by qualified clinicians. Death was defined as all-cause mortality occurring during the index hospitalization. Participants who experienced either severe IVH, death, or both were classified as meeting the combined outcome.

    Time frame: From birth through 40 weeks postmenstrual age or discharge from the initial neonatal intensive care unit (NICU) admission, whichever occurred first

27. Death

    Participants who died regardless of cause, were classified as having experienced the outcome. Date of death was determined from the medical record.

    Time frame: From birth through 40 weeks postmenstrual age or discharge from the initial neonatal intensive care unit (NICU) admission, whichever occurred first

28. Early Onset Sepsis

    Defined as culture-confirmed infection, indicated by a positive blood or cerebrospinal fluid (CSF) culture, occurring at ≤ 72 hours of life (HOL). Cultures were obtained as part of routine clinical care and interpreted according to standard microbiological criteria. Participants with at least one qualifying positive blood or CSF culture within this time frame were classified as having early-onset sepsis.

    Time frame: From birth up to 72 hours of life

29. Late Onset Sepsis

    Defined as culture-confirmed infection, indicated by a positive blood or cerebrospinal fluid (CSF) culture, occurring at \> 72 hours of life (HOL). Cultures were obtained as part of routine clinical care and interpreted according to standard microbiological criteria. Participants with at least one qualifying positive blood or CSF culture beyond 72 hours of life were classified as having late-onset sepsis.

    Time frame: From > 72 hours of life through discharge from the initial neonatal intensive care unit (NICU) admission up to 6 months of age

30. Thermoregulation Assessed by Delivery Room Axillary Temperature

    Thermoregulation was assessed by measurement of axillary body temperature, recorded in degrees Celsius (°C), in the delivery room prior to admission to the neonatal intensive care unit (NICU). A single axillary temperature measurement was obtained from 5 minutes after delivery during neonatal resuscitation and within the first hour of life. The outcome is reported as the mean axillary temperature across participants obtained at approximately 5 minutes after delivery.

    Time frame: From 5 minutes after delivery up to 1 hour after delivery or NICU admission whichever occurs first

31. Use of Inhaled Nitric Oxide for Respiratory Failure or Pulmonary Hypertension

    Use of inhaled nitric oxide (iNO) was defined as the administration of inhaled nitric oxide therapy at any time from birth through discharge from the initial neonatal intensive care unit (NICU) admission for the clinical management of hypoxic respiratory failure and/or pulmonary hypertension, as determined by the treating clinical team. Participants who received iNO during this time frame were classified as having met this outcome.

    Time frame: From birth through discharge from the initial neonatal intensive care unit (NICU) admission, up to 6 months of corrected gestational age

32. Cerebral Tissue Oxygen Saturation Assessed by Near-Infrared Spectroscopy

    Cerebral tissue oxygen saturation (StO₂) was assessed during the first 10 minutes of life using near-infrared spectroscopy (NIRS). StO₂ values, expressed as a percentage (%), were measured noninvasively as part of physiologic monitoring immediately after birth. The outcome is reported as the mean cerebral StO₂ value across participants during the first 10 minutes after delivery.

    Time frame: From Birth through the first 10 minutes of life

33. Peripheral Oxygen Saturation (SpO₂) in the First 10 Minutes

    Peripheral oxygen saturation (SpO₂) was assessed during the first 10 minutes of life using pulse oximetry. SpO₂ values, expressed as a percentage (%), were measured noninvasively as part of routine physiologic monitoring immediately after birth in the delivery room. The outcome is reported as the mean SpO₂ value across participants during the first 10 minutes after delivery.

    Time frame: Birth through the first 10 minutes after delivery

34. Right Ventricular Output by Echocardiography

    Right ventricular output measured by echocardiography as an indicator of right ventricular systolic blood flow, expressed in mL/kg/min. RVO was calculated as the product of the right ventricular outflow tract cross-sectional area, velocity-time integral (VTI), and heart rate. The RVOT VTI was obtained using pulse-wave Doppler immediately below the pulmonary valve.

    Time frame: assessed in the first 12 hours after birth

35. Superior Vena Cava Flow by Echocardiography

    Superior vena cava flow measured by echocardiography as an indicator of systemic venous return and upper body blood flow, expressed in mL/kg/min. SVC flow was calculated as the product of vessel cross-sectional area, velocity-time integral (VTI), and heart rate using pulse-wave Doppler measurements obtained from the proximal superior vena cava in the subcostal bicaval view.

    Time frame: assessed in the first 12 hours after birth

36. Left Ventricular Output

    Left ventricular output measured by echocardiography as an indicator of systemic cardiac output, expressed in mL/kg/min. LVO was calculated as the product of the left ventricular outflow tract cross-sectional area, velocity-time integral (VTI), and heart rate. The LVOT VTI was obtained using pulse-wave Doppler immediately below the aortic valve.

    Time frame: 6 hours of life

37. Pulsatility Index of the Middle Cerebral Artery

    Middle cerebral artery pulsatility index (PI) measured by transcranial Doppler ultrasound as a noninvasive indicator of cerebral blood flow pulsatility and cerebrovascular resistance, expressed as a unitless index. Measurements were obtained from Doppler waveforms of the middle cerebral artery through the temporal bone window. PI was calculated using the Gosling formula: (peak systolic velocity - end-diastolic velocity) divided by mean velocity. Higher PI values generally reflect greater cerebrovascular resistance and lower diastolic blood flow, whereas lower values reflect reduced vascular resistance and increased diastolic flow. In very preterm infants, PI may provide insight into cerebral autoregulation and cerebral hemodynamics during cardiovascular transition.

    Time frame: assessed in the first 12 hours after birth

38. Resistive Index of the Middle Cerebral Artery

    Middle cerebral artery resistive index (RI) measured by transcranial Doppler ultrasound as a noninvasive indicator of cerebral vascular resistance and arterial blood flow, expressed as a unitless index. Measurements were obtained from Doppler waveforms of the middle cerebral artery through the temporal bone window. RI was calculated as (peak systolic velocity - end-diastolic velocity) divided by peak systolic velocity. Higher RI values generally reflect greater cerebrovascular resistance and lower end-diastolic blood flow, whereas lower values reflect reduced vascular resistance and increased diastolic flow. In very preterm infants, RI may provide insight into cerebral perfusion and autoregulatory function during cardiovascular transition.

    Time frame: assessed in the first 12 hours after birth

39. Oxidative Stress Assessed by Arterial Cord Blood Reduced Glutathione (GSH)

    Oxidative stress was assessed by measuring reduced glutathione (GSH) levels in arterial cord blood samples. Arterial cord blood GSH concentration was quantified using standard laboratory assays and used as a biomarker of systemic oxidative stress and antioxidant capacity. The outcome is reported as the mean arterial cord blood GSH concentration across participants.

    Time frame: From birth up to 2 hours after delivery

40. Oxidative Stress Assessed by Oxidized Glutathione (GSSG) in Arterial Cord Blood

    Oxidative stress was assessed by measuring oxidized glutathione (GSSG) concentration in arterial cord blood samples collected at birth. GSSG levels were quantified using standard laboratory assays. The outcome is reported as the median arterial cord blood GSSG concentration across participants.

    Time frame: At birth (a segment of the umbilical cord is preserved for blood collection)

41. Oxidative Stress Assessed by Glutathione Ratio of Arterial Cord Blood (GSH/GSSG)

    Oxidative stress was assessed by measuring the ratio of reduced glutathione to oxidized glutathione (GSH/GSSG) in arterial cord blood samples collected at birth. Glutathione concentrations were quantified using standard laboratory assays, and the GSH/GSSG ratio was calculated as an indicator of cellular redox status. Reduced glutathione (GSH) is a major intracellular antioxidant, whereas oxidized glutathione (GSSG) accumulates when cells are exposed to oxidative stress. Higher GSH/GSSG ratios generally reflect a more reduced cellular environment and greater antioxidant capacity, whereas lower ratios indicate increased oxidative stress and consumption of antioxidant reserves. In newborn infants, oxidative stress may result from exposure to hypoxia, reperfusion, inflammation, or transitional physiologic changes after birth. The outcome is reported as the median GSH/GSSG ratio

    Time frame: from birth up to 2 hours of life

42. Oxidative Stress Assessed by Venous Cord Blood Reduced Glutathione (GSH)

    Oxidative stress was assessed by measuring reduced glutathione (GSH) levels in venous cord blood samples. Arterial cord blood GSH concentration was quantified using standard laboratory assays and used as a biomarker of systemic oxidative stress and antioxidant capacity. The outcome is reported as the median venous cord blood GSH concentration across participants.

    Time frame: From birth up to 2 hours after delivery

43. Oxidative Stress Assessed by Oxidized Glutathione (GSSG) in Venous Cord Blood

    Oxidative stress was assessed by measuring oxidized glutathione (GSSG) concentration in venous cord blood samples collected at birth. GSSG levels were quantified using standard laboratory assays. The outcome is reported as the median venous cord blood GSSG concentration across participants.

    Time frame: At birth (a segment of the umbilical cord is preserved for blood collection)

44. Oxidative Stress Assessed by Venous Cord Blood Glutathione Ratio (GSH/GSSG)

    Oxidative stress was assessed by measuring the ratio of reduced glutathione to oxidized glutathione (GSH/GSSG) in venous cord blood samples collected at birth. Glutathione concentrations were quantified using standard laboratory assays, and the GSH/GSSG ratio was calculated as an indicator of cellular redox status. Reduced glutathione (GSH) is a major intracellular antioxidant that helps protect cells from oxidative damage, whereas oxidized glutathione (GSSG) accumulates when reactive oxygen species are generated and antioxidant reserves are consumed. Higher GSH/GSSG ratios generally reflect a more reduced cellular environment and greater antioxidant capacity, whereas lower ratios indicate increased oxidative stress and impaired redox balance. In newborn infants, oxidative stress may occur as a result of hypoxia, reperfusion, inflammation, or physiologic adaptation during the transition from intrauterine to extrauterine life. The outcome is reported as the median GSH/GSSG ratio.

    Time frame: from birth up to 2 hours of life

45. Reduced (GSH) Glutathione Concentrations in Postnatal Blood

    Oxidative stress was assessed by measuring reduced glutathione (GSH) concentrations in blood samples collected from participants. Venous blood was analyzed when available; otherwise, arterial blood samples were used. Concentrations were quantified using standard laboratory assays. The outcome is reported as the median arterial cord blood GSH concentration across participants.

    Time frame: from birth up to 2 hours of life

46. Oxidized (GSSG) Glutathione Concentrations in Postnatal Blood

    Oxidative stress was assessed by measuring oxidized glutathione (GSSG) concentration in blood samples collected from participants. Venous blood was analyzed when available; otherwise, arterial blood samples were used. Concentrations were quantified using standard laboratory assays. The outcome is reported as the median arterial cord blood GSSG concentration across participants.

    Time frame: from birth up to 2 hours of life

47. Reduced-to-Oxidized Glutathione Ratio (GSH/GSSG) in Postnatal Blood

    Oxidative stress was assessed by measuring reduced glutathione (GSH) and oxidized glutathione (GSSG) concentrations in blood samples collected from participants. Venous blood was analyzed when available; otherwise, arterial blood samples were used. The GSH/GSSG ratio was calculated based on concentrations quantified using standard laboratory assays and reported as the median GSH/GSSG ratio across participants.

    Time frame: from birth up to 2 hours of life

48. Mean Child Behavior Checklist Total Problems T-score

    Child Behavior Checklist (CBCL) Total Problems T-scores will be assessed using the caregiver-completed CBCL instrument. Scores are standardized T-scores with higher values indicating greater behavioral and emotional problems. A T-score ≤ 59 indicates non-clinical symptoms, a t-score between 60 and 64 indicates that the child is at risk for problem behaviors, and a T-score ≥ 65 indicates clinical symptoms.

    Time frame: 2 years of age

49. Number of Participants in Each Child Behavior Checklist (CBCL) Severity Category

    Participants will be classified based on CBCL Total Problems T-score into: * Non-clinical: T-score ≤ 59 * At-risk (borderline): T-score 60-64 * Clinical: T-score ≥ 65 These thresholds are based on CBCL normative scoring guidelines.

    Time frame: 2 years of age

50. Neurodevelopmental Impairment Severity

    Neurodevelopmental outcomes were classified as two categories Normal/At-Risk/Mild Neurodevelopmental Impairment or Moderate-to-Severe Neurodevelopmental Impairment based on standardized developmental assessments, neurologic examination, vision, and hearing status. -Moderate-to-severe neurodevelopmental impairment was defined as the presence of at least one of the following: Cognitive score \< 70 Gross Motor Function Classification System (GMFCS) level ≥ 2 Bilateral blindness (visual acuity \< 20/200) Hearing impairment that interferes with the ability to communicate despite amplification -Normal/At-risk/Mild neurodevelopmental impairment was defined as having no criteria for moderate-to-severe impairment, and may include: Typical development with no impairments, Cognitive score 70-84, GMFCS level = 1, Unilateral blindness (visual acuity \< 20/200 in one eye), or Hearing impairment that does not interfere with the ability to communicate

    Time frame: assessed at 2 years of age

51. Cognitive Composite Score (Bayley-4)

    Cognitive Composite Score of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4). The Cognitive Composite Score ranges from 45 to 155, with higher scores indicating better cognitive performance. The outcome is reported as the mean Cognitive Composite Score across participants in each group.

    Time frame: assessed at 2 years of age

52. Language Composite Score of the Bayley Scales of Infant and Toddler Development, Fourth Edition

    The Bayley-4 Language Composite Score ranges from 45 to 155, with higher scores indicating better language performance. The outcome is reported as the mean Language Composite Score across participants in each group.

    Time frame: assessed at 2 years of age

53. Motor Composite Score of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4)

    The Bayley-4 Motor Composite Score ranges from 45 to 155, with higher scores indicating better motor performance. The outcome is reported as the mean Motor Composite Score across participants

    Time frame: assessed at 2 years of age

54. Cerebral Palsy: Classified as None, Mild, Moderate or Severe Per Gross Motor Function Classification System and Neurologic Examination

    This outcome reports the number of participants classified by cerebral palsy severity (None, Mild, Moderate, or Severe) among a high-risk neonatal population of premature infants born at 24-29+6 weeks gestational age. Cerebral palsy diagnosis was determined based on clinical neurologic examination. Functional severity was categorized using gross motor function assessed by the Gross Motor Function Classification System (GMFCS) as follows: Mild (GMFCS Level I), Moderate (GMFCS Levels II-III), and Severe (GMFCS Levels IV-V). Participants classified as None had no diagnosis of cerebral palsy on neurologic examination. GMFCS levels were used to describe functional severity and not to establish the diagnosis.

    Time frame: assessed at 2 years of age

55. Overall Score- Ages and Stages, 3rd ed. Questionnaire

    For each of the 5 domains: Communication, Gross Motor, Fine Motor, Problem Solving, and Personal-Social, responses are scored and summed to produce a domain-specific score ranging from 0 to 60, with higher scores indicating more typical developmental skills in that domain. Results are reported as the mean domain score foreach study group.

    Time frame: assessed at 2 years of age

56. Gross Motor Function Classification System (GMFCS) Score

    GMFCS score: A validated system used to describe the severity of motor dysfunction. Scale measured from Level 0-5 with Level 0 being normal and Level 5 being the worst score. Measures the child's ability to walk, sit, head control, voluntary movements and postures.

    Time frame: assessed at 2 years of age

57. Cerebral Palsy Classification as None, Mild, Moderate or Severe Per Gross Motor Function Classification System (GMFCS) Score

    Cerebral Palsy: Classified as None, Mild, Moderate or Severe per GMFCS and neurologic examination

    Time frame: assessed at 2years of age

Baseline characteristics

9 further baseline measures are reported on the registry.

Publications

• Mercer JS, McGrath MM, Hensman A, Silver H, Oh W. Immediate and delayed cord clamping in infants born between 24 and 32 weeks: a pilot randomized controlled trial. J Perinatol. 2003 Sep;23(6):466-72. doi: 10.1038/sj.jp.7210970. PubMed 13679933 ↗
• Rabe H, Jewison A, Fernandez Alvarez R, Crook D, Stilton D, Bradley R, Holden D; Brighton Perinatal Study Group. Milking compared with delayed cord clamping to increase placental transfusion in preterm neonates: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):205-211. doi: 10.1097/AOG.0b013e3181fe46ff. PubMed 21252731 ↗
• Mercer JS, Vohr BR, McGrath MM, Padbury JF, Wallach M, Oh W. Delayed cord clamping in very preterm infants reduces the incidence of intraventricular hemorrhage and late-onset sepsis: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):1235-42. doi: 10.1542/peds.2005-1706. PubMed 16585320 ↗
• Hofmeyr GJ, Bolton KD, Bowen DC, Govan JJ. Periventricular/intraventricular haemorrhage and umbilical cord clamping. Findings and hypothesis. S Afr Med J. 1988 Jan 23;73(2):104-6. PubMed 3340910 ↗
• Hofmeyr GJ, Gobetz L, Bex PJ, Van der Griendt M, Nikodem C, Skapinker R, Delahunt T. Periventricular/intraventricular hemorrhage following early and delayed umbilical cord clamping. A randomized controlled trial. Online J Curr Clin Trials. 1993 Dec 29;Doc No 110:[2002 words; 26 paragraphs]. PubMed 8305996 ↗
• Rabe H, Reynolds G, Diaz-Rossello J. Early versus delayed umbilical cord clamping in preterm infants. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD003248. doi: 10.1002/14651858.CD003248.pub2. PubMed 15495045 ↗
• Fogarty M, Osborn DA, Askie L, Seidler AL, Hunter K, Lui K, Simes J, Tarnow-Mordi W. Delayed vs early umbilical cord clamping for preterm infants: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018 Jan;218(1):1-18. doi: 10.1016/j.ajog.2017.10.231. Epub 2017 Oct 30. PubMed 29097178 ↗
• Wyllie J, Perlman JM, Kattwinkel J, Wyckoff MH, Aziz K, Guinsburg R, Kim HS, Liley HG, Mildenhall L, Simon WM, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 7: Neonatal resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Resuscitation. 2015 Oct;95:e169-201. doi: 10.1016/j.resuscitation.2015.07.045. Epub 2015 Oct 15. No abstract available. PubMed 26477424 ↗
• Polglase GR, Dawson JA, Kluckow M, Gill AW, Davis PG, Te Pas AB, Crossley KJ, McDougall A, Wallace EM, Hooper SB. Ventilation onset prior to umbilical cord clamping (physiological-based cord clamping) improves systemic and cerebral oxygenation in preterm lambs. PLoS One. 2015 Feb 17;10(2):e0117504. doi: 10.1371/journal.pone.0117504. eCollection 2015. PubMed 25689406 ↗
• Hooper SB, Te Pas AB, Lang J, van Vonderen JJ, Roehr CC, Kluckow M, Gill AW, Wallace EM, Polglase GR. Cardiovascular transition at birth: a physiological sequence. Pediatr Res. 2015 May;77(5):608-14. doi: 10.1038/pr.2015.21. Epub 2015 Feb 4. PubMed 25671807 ↗
• Bhatt S, Polglase GR, Wallace EM, Te Pas AB, Hooper SB. Ventilation before Umbilical Cord Clamping Improves the Physiological Transition at Birth. Front Pediatr. 2014 Oct 20;2:113. doi: 10.3389/fped.2014.00113. eCollection 2014. PubMed 25368858 ↗
• Katheria A, Reister F, Essers J, Mendler M, Hummler H, Subramaniam A, Carlo W, Tita A, Truong G, Davis-Nelson S, Schmolzer G, Chari R, Kaempf J, Tomlinson M, Yanowitz T, Beck S, Simhan H, Dempsey E, O'Donoghue K, Bhat S, Hoffman M, Faksh A, Arnell K, Rich W, Finer N, Vaucher Y, Khanna P, Meyers M, Varner M, Allman P, Szychowski J, Cutter G. Association of Umbilical Cord Milking vs Delayed Umbilical Cord Clamping With Death or Severe Intraventricular Hemorrhage Among Preterm Infants. JAMA. 2019 Nov 19;322(19):1877-1886. doi: 10.1001/jama.2019.16004. PubMed 31742630 ↗
• Katheria AC, Hassen K, Rich W, Poeltler D, Finer N. Resuscitation outcomes of infants that do not achieve a 5 min target SpO2 saturation. J Perinatol. 2019 Dec;39(12):1635-1639. doi: 10.1038/s41372-019-0491-x. Epub 2019 Sep 5. PubMed 31488904 ↗
• Oei JL, Finer NN, Saugstad OD, Wright IM, Rabi Y, Tarnow-Mordi W, Rich W, Kapadia V, Rook D, Smyth JP, Lui K, Vento M. Outcomes of oxygen saturation targeting during delivery room stabilisation of preterm infants. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F446-F454. doi: 10.1136/archdischild-2016-312366. Epub 2017 Oct 7. PubMed 28988158 ↗
• Katheria A, Poeltler D, Durham J, Steen J, Rich W, Arnell K, Maldonado M, Cousins L, Finer N. Neonatal Resuscitation with an Intact Cord: A Randomized Clinical Trial. J Pediatr. 2016 Nov;178:75-80.e3. doi: 10.1016/j.jpeds.2016.07.053. Epub 2016 Aug 26. PubMed 27574999 ↗
• Duley L, Dorling J, Pushpa-Rajah A, Oddie SJ, Yoxall CW, Schoonakker B, Bradshaw L, Mitchell EJ, Fawke JA; Cord Pilot Trial Collaborative Group. Randomised trial of cord clamping and initial stabilisation at very preterm birth. Arch Dis Child Fetal Neonatal Ed. 2018 Jan;103(1):F6-F14. doi: 10.1136/archdischild-2016-312567. Epub 2017 Sep 18. PubMed 28923985 ↗
• Dekker J, Martherus T, Lopriore E, Giera M, McGillick EV, Hutten J, van Leuteren RW, van Kaam AH, Hooper SB, Te Pas AB. The Effect of Initial High vs. Low FiO2 on Breathing Effort in Preterm Infants at Birth: A Randomized Controlled Trial. Front Pediatr. 2019 Dec 12;7:504. doi: 10.3389/fped.2019.00504. eCollection 2019. PubMed 31921719 ↗
• Vaucher YE, Peralta-Carcelen M, Finer NN, Carlo WA, Gantz MG, Walsh MC, Laptook AR, Yoder BA, Faix RG, Das A, Schibler K, Rich W, Newman NS, Vohr BR, Yolton K, Heyne RJ, Wilson-Costello DE, Evans PW, Goldstein RF, Acarregui MJ, Adams-Chapman I, Pappas A, Hintz SR, Poindexter B, Dusick AM, McGowan EC, Ehrenkranz RA, Bodnar A, Bauer CR, Fuller J, O'Shea TM, Myers GJ, Higgins RD; SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network. Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial. N Engl J Med. 2012 Dec 27;367(26):2495-504. doi: 10.1056/NEJMoa1208506. PubMed 23268664 ↗
• Bhatt S, Alison BJ, Wallace EM, Crossley KJ, Gill AW, Kluckow M, te Pas AB, Morley CJ, Polglase GR, Hooper SB. Delaying cord clamping until ventilation onset improves cardiovascular function at birth in preterm lambs. J Physiol. 2013 Apr 15;591(8):2113-26. doi: 10.1113/jphysiol.2012.250084. Epub 2013 Feb 11. PubMed 23401615 ↗
• Crawshaw JR, Kitchen MJ, Binder-Heschl C, Thio M, Wallace MJ, Kerr LT, Roehr CC, Lee KL, Buckley GA, Davis PG, Flemmer A, Te Pas AB, Hooper SB. Laryngeal closure impedes non-invasive ventilation at birth. Arch Dis Child Fetal Neonatal Ed. 2018 Mar;103(2):F112-F119. doi: 10.1136/archdischild-2017-312681. Epub 2017 Oct 20. PubMed 29054974 ↗
• van Vonderen JJ, Hooper SB, Hummler HD, Lopriore E, te Pas AB. Effects of a sustained inflation in preterm infants at birth. J Pediatr. 2014 Nov;165(5):903-8.e1. doi: 10.1016/j.jpeds.2014.06.007. Epub 2014 Jul 16. PubMed 25039041 ↗
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• Katheria AC, Brown MK, Faksh A, Hassen KO, Rich W, Lazarus D, Steen J, Daneshmand SS, Finer NN. Delayed Cord Clamping in Newborns Born at Term at Risk for Resuscitation: A Feasibility Randomized Clinical Trial. J Pediatr. 2017 Aug;187:313-317.e1. doi: 10.1016/j.jpeds.2017.04.033. Epub 2017 May 16. PubMed 28526223 ↗
• Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Committee Opinion No.543: Timing of umbilical cord clamping after birth. Obstet Gynecol. 2012 Dec;120(6):1522-6. doi: 10.1097/01.AOG.0000423817.47165.48. PubMed 23168790 ↗
• Perlman JM, Wyllie J, Kattwinkel J, Wyckoff MH, Aziz K, Guinsburg R, Kim HS, Liley HG, Mildenhall L, Simon WM, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 7: Neonatal Resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2015 Oct 20;132(16 Suppl 1):S204-41. doi: 10.1161/CIR.0000000000000276. No abstract available. PubMed 26472855 ↗
• Vento M, Aguar M, Escobar J, Arduini A, Escrig R, Brugada M, Izquierdo I, Asensi MA, Sastre J, Saenz P, Gimeno A. Antenatal steroids and antioxidant enzyme activity in preterm infants: influence of gender and timing. Antioxid Redox Signal. 2009 Dec;11(12):2945-55. doi: 10.1089/ars.2009.2671. PubMed 19645572 ↗
• Egan EA, Olver RE, Strang LB. Changes in non-electrolyte permeability of alveoli and the absorption of lung liquid at the start of breathing in the lamb. J Physiol. 1975 Jan;244(1):161-79. doi: 10.1113/jphysiol.1975.sp010789. PubMed 1123740 ↗
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• Zhang Y, Chan GS, Tracy MB, Lee QY, Hinder M, Savkin AV, Lovell NH. Cerebral near-infrared spectroscopy analysis in preterm infants with intraventricular hemorrhage. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:1937-40. doi: 10.1109/IEMBS.2011.6090547. PubMed 22254711 ↗
• Sorensen LC, Maroun LL, Borch K, Lou HC, Greisen G. Neonatal cerebral oxygenation is not linked to foetal vasculitis and predicts intraventricular haemorrhage in preterm infants. Acta Paediatr. 2008 Nov;97(11):1529-34. doi: 10.1111/j.1651-2227.2008.00970.x. Epub 2008 Jul 31. PubMed 18673361 ↗
• Raju TN. Research in perinatal and neonatal medicine--a scientific vision for future decades. Indian J Pediatr. 2014 Jun;81(6):570-7. doi: 10.1007/s12098-014-1467-7. Epub 2014 May 14. PubMed 24820234 ↗
• Fanaroff JM, Wilson-Costello DE, Newman NS, Montpetite MM, Fanaroff AA. Treated hypotension is associated with neonatal morbidity and hearing loss in extremely low birth weight infants. Pediatrics. 2006 Apr;117(4):1131-5. doi: 10.1542/peds.2005-1230. PubMed 16585307 ↗
• Fanaroff AA, Fanaroff JM. Short- and long-term consequences of hypotension in ELBW infants. Semin Perinatol. 2006 Jun;30(3):151-5. doi: 10.1053/j.semperi.2006.04.006. PubMed 16813974 ↗
• Laughon M, Bose C, Allred E, O'Shea TM, Van Marter LJ, Bednarek F, Leviton A; ELGAN Study Investigators. Factors associated with treatment for hypotension in extremely low gestational age newborns during the first postnatal week. Pediatrics. 2007 Feb;119(2):273-80. doi: 10.1542/peds.2006-1138. PubMed 17272616 ↗
• Paradisis M, Evans N, Kluckow M, Osborn D. Randomized trial of milrinone versus placebo for prevention of low systemic blood flow in very preterm infants. J Pediatr. 2009 Feb;154(2):189-95. doi: 10.1016/j.jpeds.2008.07.059. Epub 2008 Sep 25. PubMed 18822428 ↗
• Bravo MC, Lopez-Ortego P, Sanchez L, Riera J, Madero R, Cabanas F, Pellicer A. Randomized, Placebo-Controlled Trial of Dobutamine for Low Superior Vena Cava Flow in Infants. J Pediatr. 2015 Sep;167(3):572-8.e1-2. doi: 10.1016/j.jpeds.2015.05.037. Epub 2015 Jun 24. PubMed 26116470 ↗
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• Rich WD, Leone T, Finer NN. Delivery room intervention: improving the outcome. Clin Perinatol. 2010 Mar;37(1):189-202. doi: 10.1016/j.clp.2010.01.011. PubMed 20363455 ↗
• Vento M, Aguar M, Leone TA, Finer NN, Gimeno A, Rich W, Saenz P, Escrig R, Brugada M. Using intensive care technology in the delivery room: a new concept for the resuscitation of extremely preterm neonates. Pediatrics. 2008 Nov;122(5):1113-6. doi: 10.1542/peds.2008-1422. No abstract available. PubMed 18977992 ↗
• Garey DM, Ward R, Rich W, Heldt G, Leone T, Finer NN. Tidal volume threshold for colorimetric carbon dioxide detectors available for use in neonates. Pediatrics. 2008 Jun;121(6):e1524-7. doi: 10.1542/peds.2007-2708. Epub 2008 May 5. PubMed 18458036 ↗
• Leone TA, Lange A, Rich W, Finer NN. Disposable colorimetric carbon dioxide detector use as an indicator of a patent airway during noninvasive mask ventilation. Pediatrics. 2006 Jul;118(1):e202-4. doi: 10.1542/peds.2005-2493. Epub 2006 Jun 26. PubMed 16801392 ↗
• Wang CL, Anderson C, Leone TA, Rich W, Govindaswami B, Finer NN. Resuscitation of preterm neonates by using room air or 100% oxygen. Pediatrics. 2008 Jun;121(6):1083-9. doi: 10.1542/peds.2007-1460. PubMed 18519476 ↗
• Katheria AC, Harbert MJ, Nagaraj SB, Arnell K, Poeltler DM, Brown MK, Rich W, Hassen KO, Finer N. The Neu-Prem Trial: Neuromonitoring of Brains of Infants Born Preterm During Resuscitation-A Prospective Observational Cohort Study. J Pediatr. 2018 Jul;198:209-213.e3. doi: 10.1016/j.jpeds.2018.02.065. Epub 2018 Apr 18. PubMed 29680471 ↗
• Katheria AC, Leone TA, Woelkers D, Garey DM, Rich W, Finer NN. The effects of umbilical cord milking on hemodynamics and neonatal outcomes in premature neonates. J Pediatr. 2014 May;164(5):1045-1050.e1. doi: 10.1016/j.jpeds.2014.01.024. Epub 2014 Feb 20. PubMed 24560179 ↗
• Katheria AC, Truong G, Cousins L, Oshiro B, Finer NN. Umbilical Cord Milking Versus Delayed Cord Clamping in Preterm Infants. Pediatrics. 2015 Jul;136(1):61-9. doi: 10.1542/peds.2015-0368. PubMed 26122803 ↗
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• Katheria AC, Ines F, Lee HC, Sollinger C, Vali P, Morales A, Sanjay S, Dorner R, Koo J, Gollin Y, Das A, Poeltler D, Steinhorn R, Finer N, Lakshminrusimha S. Deferred Cord Clamping With High Oxygen in Extremely Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2025 Sep 1;179(9):971-978. doi: 10.1001/jamapediatrics.2025.2128. PubMed 40690234 ↗

Study documents

• Study protocol ↗ · Mar 29, 2024
• Statistical analysis plan ↗ · Oct 10, 2024

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Data will be made available per NICHD requirements (National Institute of Child Health and Human Development)

Supporting information: Statistical analysis plan

Time frame: 2 years after primary publication

Access criteria: An archived dataset with documentation will be made available for additional users by outside investigators, in collaboration with the study investigators. We will work with NICHD program staff to develop a broad data sharing plan over time.