An interventional study of Umbilical Cord Milking and Early Cord Clamping in Birth Asphyxia, sponsored by Sharp HealthCare. Completed at 10 sites in 3 countries. Open to participants aged 35 Weeks to 42 Weeks. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Sharp HealthCare · Not applicable, Interventional, and Prevention
The investigators will conduct a study of non-vigorous term infants to determine if umbilical cord milking (UCM) results in a lower rate of NICU admissions than early clamping and cutting of the umbilical cord at birth for infants who need resuscitation.
At birth, it is critical that an infant begins breathing quickly. The infant has to switch from relying on the placenta for oxygen to using its lungs for the first time. The currently recommended practice for infants who need resuscitation is to immediately clamp the umbilical cord. Animal studies show that clamping the cord before the baby breathes can cause the heart beat to slow and can decrease the amount of blood being pumped out of the heart each minute. This study will test whether infants will benefit from UCM. The cord will be quickly milked four times before cutting and will not delay the resuscitation procedures. This study is important because when there is need for resuscitation, neither UCM or delayed cord clamping, are recommended by national and international organizations due to lack of evidence. Yet, several large studies from around the world have identified that infants needing resuscitation are more likely to develop conditions such as cerebral palsy, autism and other developmental problems.
The trial is a cluster crossover design in which each hospital will be randomly assigned to use either early cord clamping or UCM for any infant needing resuscitation over a period of 12 months. Then sites will change to the other method for an additional 12 months.
106 studies on the registry are indexed under Asphyxia Neonatorum; 19 are open to participants now.
This study's enrollment of 1,730 is above the median of 173 across 73 interventional studies indexed under Asphyxia Neonatorum.
Browse Asphyxia Neonatorum studies →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.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk the entire length of umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for ECC as we have demonstrated in our previous trials.
Procedure: Umbilical Cord Milking
This will occur by clamping the umbilical cord as soon as possible. Since both ECC and UCM will occur after a brief assessment, it is important to note that the cord clamping time will be longer than in previously conducted preterm trials (average 20 seconds) which performed the intervention on all subjects regardless of whether or not they were vigorous. In all cases, the cord clamping time will be documented to ensure consistency.
Procedure: Early Cord Clamping
At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds.
The umbilical cord is clamped within 60 seconds of delivery.
Number of Neonatal Participants Admitted to the NICU for Predefined Criteria
Number of neonatal participants admitted to the neonatal intensive care unit for study-specific predefined criteria including respiratory distress, oxygen desaturation, hypoglycemia, hypotonia, apnea, lethargy or difficulty arousing, hypertonia or irritability, temperature instability, bradycardia or tachycardia, seizures or seizure-like activity, poor feeding or emesis, hyperbilirubinemia, death before NICU admission.
Time frame: Birth to first 48 hours of life.
Median Neonatal Hemoglobin Between 12 to 48 Hours of Life
Single hemoglobin measurement for the neonate which was obtained between 12 to 48 hours of life collected with written consent or as part of standard care.
Time frame: 12-48 hours of life
Number of Neonates Treated With Therapeutic Hypothermia ("Cooling")
Number of neonates that were treated with therapeutic hypothermia (Cooling to 33.5 degrees Celsius) for 72 hours and initiated within the first 6 hours of life.
Time frame: Birth to 78 hours of life.
Number of Neonates Treated With Normal Saline Bolus in the First 24 Hours of Life
Number of neonates treated with normal saline bolus in the first 24 hours of life to support blood pressure.
Time frame: Birth through 24 hours of life
Median Peak Total Serum Bilirubin in Neonates
Highest single measurement of total serum bilirubin obtained as part of standard care to assess hyperbilirubinemia in neonate.
Time frame: First week of life
Median Transcutaneous Bilirubin in Neonates
Highest single measurement of transcutaneous bilirubin obtained as part of standard care to assess hyperbilirubinemia in each neonate.
Time frame: birth to 7 days of life
Number of Neonatal Deaths
Number of neonatal deaths prior to discharge
Time frame: Birth to discharge, assessed up to 180 days of life.
Number of Neonates Diagnosed With Mild, Moderate or Severe Hypoxic Ischemic Encephalopathy
Number of neonates with a diagnosis of mild, moderate or severe hypoxic ischemic encephalopathy during neonatal intensive care unit admission.
Time frame: Birth to discharge, up to 120 days of life.
Median Length of Neonate's Hospitalization in Days Among Participants Discharged Alive
Number of days neonate was admitted to the neonatal intensive care unit from birth to discharge home.
Time frame: birth to discharge, up to 120 days of life.
Median Neonatal Admission Blood Pressure
First single neonatal blood pressure measurement by cuff or arterial line obtained on admission to the neonatal intensive care unit and by 48 hours of life.
Time frame: Birth to 48 hours of life.
Number of Neonates With Any Cardiorespiratory Support Intervention at Birth
Neonates were assessed for poor tone, poor color (pale, dusky, cyanotic) and poor breathing effort by obstetric provider as part of standard care. Resuscitation assessment and interventions were conducted by neonatal intensive care clinical team. Recorded resuscitation interventions included: use of supplemental oxygen, continuous positive airway pressure respiratory support, positive pressure ventilation respiratory support, endotracheal intubation, chest compressions, epinephrine, normal saline bolus and other cardiorespiratory support medications. Resuscitation interventions including cardiorespiratory support were determined by individual site's clinical standards.
Time frame: Birth to first hour of life.
10 sites were randomized to perform umbilical cord milking or early cord clamping for eligible neonate-mother dyads. Research staff at each sites approached eligible neonate-mother dyads after delivery for written informed consent for additional data collection. Hospital recruited neonate-mother dyads in the initial period from January 2019 to January 2020 and from February 2020 and May 2021 for the crossover period. Neonate-mother dyads participated in a single period of the study.
| Milestone | Umbilical Cord Milking, Then Early Cord Clamping - Neonate-Mother Dyad | Early Cord Clamping, Then Umbilical Cord Milking - Neonate-Mother Dyad |
|---|---|---|
| Started | 366 | 494 |
| Completed | 366 | 494 |
| Not completed | 0 | 0 |
| Milestone | Umbilical Cord Milking, Then Early Cord Clamping - Neonate-Mother Dyad | Early Cord Clamping, Then Umbilical Cord Milking - Neonate-Mother Dyad |
|---|---|---|
| Started | 364 | 506 |
| Completed | 364 | 506 |
| Not completed | 0 | 0 |
Number of neonatal participants admitted to the neonatal intensive care unit for study-specific predefined criteria including respiratory distress, oxygen desaturation, hypoglycemia, hypotonia, apnea, lethargy or difficulty arousing, hypertonia or irritability, temperature instability, bradycardia or tachycardia, seizures or seizure-like activity, poor feeding or emesis, hyperbilirubinemia, death before NICU admission.
| Participants | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate |
|---|---|---|
| Total number of neonates admitted to the neonatal intensive care unit for predefined criteria | 199 | 239 |
| Total number of neonates admitted to neonatal intensive care unit for other criteria | 53 | 52 |
| Total number of neonates without a neonatal intensive care unit admission | 620 | 567 |
Single hemoglobin measurement for the neonate which was obtained between 12 to 48 hours of life collected with written consent or as part of standard care.
| g/dL | Umbilical Cord Milking - Neonates | Early Cord Clamping - Neonates |
|---|---|---|
| Median Neonatal Hemoglobin Between 12 to 48 Hours of Life | 18.0 (16.3 to 19.4) | 17.3 (15.7 to 18.8) |
Number of neonates that were treated with therapeutic hypothermia (Cooling to 33.5 degrees Celsius) for 72 hours and initiated within the first 6 hours of life.
| Participants | Umbilical Cord Milking - Neonates | Early Cord Clamping - Neonates |
|---|---|---|
| Number of Neonates Treated With Therapeutic Hypothermia ("Cooling") | 21 | 35 |
Number of neonates treated with normal saline bolus in the first 24 hours of life to support blood pressure.
| Participants | Umbilical Cord Milking - Neonates | Early Cord Clamping - Neonates |
|---|---|---|
| Number of Neonates Treated With Normal Saline Bolus in the First 24 Hours of Life | 58 | 56 |
Highest single measurement of total serum bilirubin obtained as part of standard care to assess hyperbilirubinemia in neonate.
| mg/dL | Umbilical Cord Milking - Neonates | Early Cord Clamping - Neonates |
|---|---|---|
| Median Peak Total Serum Bilirubin in Neonates | 8.4 (5.9 to 11.5) | 7 (5.5 to 10.1) |
Highest single measurement of transcutaneous bilirubin obtained as part of standard care to assess hyperbilirubinemia in each neonate.
| mg/dL | Umbilical Cord Milking - Neonates | Early Cord Clamping - Neonates |
|---|---|---|
| Median Transcutaneous Bilirubin in Neonates | 7.1 (5.2 to 9.5) | 6.5 (4.7 to 8.8) |
Number of neonatal deaths prior to discharge
| Participants | Umbilical Cord Milking - Neonates | Early Cord Clamping - Neonates |
|---|---|---|
| Number of Neonatal Deaths | 0 | 4 |
Number of neonates with a diagnosis of mild, moderate or severe hypoxic ischemic encephalopathy during neonatal intensive care unit admission.
| Participants | Umbilical Cord Milking - Neonates | Early Cord Clamping - Neonates |
|---|---|---|
| Neonates with a diagnosis of mild hypoxic ischemic encephalopathy | 15 | 14 |
| Neonates with a diagnosis of moderate hypoxic ischemic encephalopathy | 8 | 19 |
| Neonates with a diagnosis of severe hypoxic ischemic encephalopathy | 4 | 5 |
| Neonates with no hypoxic ischemic encephalopathy diagnosis | 801 | 768 |
Number of days neonate was admitted to the neonatal intensive care unit from birth to discharge home.
| days | Umbilical Cord Milking - Neonates | Early Cord Clamping - Neonates |
|---|---|---|
| Median Length of Neonate's Hospitalization in Days Among Participants Discharged Alive | 3 (3 to 5) | 3 (3 to 4) |
First single neonatal blood pressure measurement by cuff or arterial line obtained on admission to the neonatal intensive care unit and by 48 hours of life.
| mm Hg | Umbilical Cord Milking - Neonates | Early Cord Clamping - Neonates |
|---|---|---|
| Median Neonatal Admission Blood Pressure | 48 (43 to 56) | 46 (41 to 54) |
Neonates were assessed for poor tone, poor color (pale, dusky, cyanotic) and poor breathing effort by obstetric provider as part of standard care. Resuscitation assessment and interventions were conducted by neonatal intensive care clinical team. Recorded resuscitation interventions included: use of supplemental oxygen, continuous positive airway pressure respiratory support, positive pressure ventilation respiratory support, endotracheal intubation, chest compressions, epinephrine, normal saline bolus and other cardiorespiratory support medications. Resuscitation interventions including cardiorespiratory support were determined by individual site's clinical standards.
| Participants | Umbilical Cord Milking - Neonatal | Early Cord Clamping - Neonatal |
|---|---|---|
| Number of neonates who received supplemental oxygen support in the delivery room | 267 | 337 |
| Number of neonates who received continuous positive airway pressure support in the delivery room | 295 | 305 |
| Number of neonates who received positive pressure ventilation support in the delivery room | 313 | 377 |
| Number of neonates who received endotracheal intubation in the delivery room | 26 | 35 |
| Number of neonates who received chest compressions in the delivery room | 9 | 7 |
| Number of neonates administered epinephrine, fluid bolus or other medication in the delivery room | 2 | 3 |
| Number of neonates with no cardiorespiratory support in the delivery room | 298 | 216 |
Collected over Neonate's birth to discharge home up to 180 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Umbilical Cord Milking-Neonates | 0/872 (0%) | 1/872 (0.1%) | 4/872 (0.5%) |
| Early Cord Clamping-Neonates | 4/858 (0.5%) | 2/858 (0.2%) | 2/858 (0.2%) |
| Event | Umbilical Cord Milking-Neonates | Early Cord Clamping-Neonates |
|---|---|---|
| Neonates with intraventricular hemorrhage grade 3 or 4 as assessed by head ultrasound or MRINervous system disorders | 1/872 | 2/858 |
| Neonates with polycythemiaBlood and lymphatic system disorders | 0/872 | 0/858 |
| Neonates with pulmonary hemorrhageVascular disorders | 0/872 | 0/858 |
| Neonates with hyperbilirubinemia requiring an exchange transfusionBlood and lymphatic system disorders | 0/872 | 0/858 |
| Event | Umbilical Cord Milking-Neonates | Early Cord Clamping-Neonates |
|---|---|---|
| Neonates with intraventricular hemorrhage grade 1Nervous system disorders | 3/872 | 2/858 |
| Neonates with intraventricular hemorrhage grade 2Nervous system disorders | 1/872 | 0/858 |
Baseline data was collected from participants who provided written consent for additional data collection or via waiver of consent for sites with ethics board approval. Maternal sex and region of enrollment were not collected.
| Age, Continuous(weeks) | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate | Total |
|---|---|---|---|
| Infants gestational age at birth | 39.3 (38.1 to 40.3) | 39.4 (38.1 to 40.3) | 39.3 (38.1 to 40.3) |
| Age, Continuous(years) | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate | Total |
|---|---|---|---|
| Maternal age at time of delivery | 31 (27 to 35) | 30 (27 to 35) | 31 (27 to 35) |
| Sex: Female, Male(Participants) | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate | Total |
|---|---|---|---|
| Neonatal Sex — Female | 375 | 355 | 730 |
| Neonatal Sex — Male | 460 | 455 | 915 |
| Ethnicity (NIH/OMB)(Participants) | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate | Total |
|---|---|---|---|
| Neonatal Ethnicity — Hispanic or Latino | 113 | 152 | 265 |
| Neonatal Ethnicity — Not Hispanic or Latino | 460 | 379 | 839 |
| Neonatal Ethnicity — Unknown or Not Reported | 299 | 327 | 626 |
| Race (NIH/OMB)(Participants) | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate | Total |
|---|---|---|---|
| Neonatal Race — American Indian or Alaska Native | 9 | 5 | 14 |
| Neonatal Race — Asian | 39 | 45 | 84 |
| Neonatal Race — Native Hawaiian or Other Pacific Islander | 2 | 7 | 9 |
| Neonatal Race — Black or African American | 50 | 47 | 97 |
| Neonatal Race — White | 333 | 320 | 653 |
| Neonatal Race — More than one race | 102 | 107 | 209 |
| Neonatal Race — Unknown or Not Reported | 337 | 327 | 664 |
| Race/Ethnicity, Customized(Participants) | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate | Total |
|---|---|---|---|
| Non-Hispanic Black Mother | 55 | 53 | 108 |
| Non-Hispanic Asian Mother | 49 | 56 | 105 |
| Non-Hispanic White Mother | 338 | 303 | 641 |
| Non-Hispanic Native American Mother | 14 | 5 | 19 |
| Non-Hispanic Pacific Islander Mother | 6 | 9 | 15 |
| Non-Hispanic Multiracial Mother | 16 | 22 | 38 |
| Maternal ethnicity/race not stated or unknown | 297 | 274 | 571 |
| Hispanic Mother | 97 | 136 | 233 |
| Region of Enrollment(neonate participants) | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate | Total |
|---|---|---|---|
| Canada | 227 | 228 | 455 |
| United States | 625 | 602 | 1227 |
| Poland | 20 | 28 | 48 |
| Maternal age(years) | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate | Total |
|---|---|---|---|
| Median | 31 (27 to 35) | 30 (27 to 35) | 31 (27 to 35) |
11 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2019 to primary completion in Jun 2021, 28 months.
Results were first posted in Sep 2024, 3 years 3 months after primary completion.
Of 33 non-industry interventional studies with no phase under Asphyxia Neonatorum, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's 28 months is above that.
Counting every sponsor, half of 33 studies reached it within 15 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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