An interventional study of New Life Box Respiratory Function Monitor in Resuscitation, Neonatal Prematurity and Positive-Pressure Respiration, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 24 Weeks to 28 Weeks. Per ClinicalTrials.gov, last updated 2021-11-22.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Health services research
This is a randomized trial to determine if a visible respiratory function monitor (RFM) displaying realtime measurements of delivered inflations improves clinical providers ability to perform positive pressure ventilation (PPV) within a pre-defined target tidal volume in preterm infants after birth.
Recently, it has been demonstrated that the use of a respiratory function monitor (RFM) can guide PPV in the DR.(Wood, Schmolzer) In this study, the New Life Box, (Advanced Life Diagnostics, Weener, Germany) a neonatal Respiratory Monitor (RFM), will be used to measure and calculate inflation pressures, flow, and tidal volumes in all enrolled infants. The New Life Box uses a small variable orifice anemometer to measure gas flow in and out of a face-mask or endotracheal tube. This signal is automatically integrated to provide inspired (Vti) and expired (Vte) tidal volume. The difference equals the leak from the facemask or endotracheal tube. Complete airway obstruction occurs when no flow of gas into or away from the infant is seen during a positive pressure inflation. The RFM can also calculate and measure respiratory rate and minute volume, inflations and spontaneous inspirations, and all ventilation pressures. Using customized software heart rate, oxygen saturation and expired carbon dioxide can be integrated into the RFM.
The NewLife Box monitor presents graphical information for pressure, flow, and volume. In addition, the monitor displays numeric data for pressure (PIP and PEEP), tidal volume (Vti, Vte), flow, respiratory rate and percent leak. The monitor integrates and displays physiologic data streaming from the patient (heart rate and oxygen saturation) as well as FiO2 from an oxygen analyzer in the inspiratory limb of the respiratory circuit. If enabled, the monitor can incorporate video captured from an external camera. The video serves as a helpful aid in the interpretation of the events during the RFM waveform recordings.
The use of an RFM in the DR has the potential to improve neonatal respiratory support and reduce lung injury.
The primary objective of this study is to test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks gestation) after birth will increase the proportion of inflations performed with a predefined VTe "safe range" of 4 - 8 mls/kg.
Exclusion Criteria:
During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.
Device: New Life Box Respiratory Function Monitor
During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.
The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.
Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg
To test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks gestation) after birth will increase the percentage of inflations performed with a predefined VTe "safe range" of 4 - 8 mls/kg.
Time frame: the first 15 minutes of resuscitation
Percentage of Oxygen Saturation (SpO2) in the First 5 Minutes of Life
Median percentage of oxygen saturation (SpO2) captured on the Respiratory Function Monitor in the first 5 minutes of life
Time frame: approximately first 5 minutes of life
Heart Rate in the First 10 Minutes of Life
Median Heart rate captured on the Respiratory Function Monitor between 3 and10 minutes of life
Time frame: between 3 and 10 minutes of life
Percentage of Time With Mask Leak During PPV Ventilation
Percentage of time with significant mask leak (defined as \> 60%) during the duration of PPV ventilation per infant in the first 15 minutes of resuscitation.
Time frame: approximately first 15 minutes of resuscitation
Percentage of PPV Inflations With Airway Obstruction
Percentage of PPV inflations with airway obstruction in the first 15 minutes of resuscitation. Airway obstruction is defined as Vte \<1 mL/kg, with minimal mask leak (\<25%) during an inflation and flattening of the flow waves.
Time frame: approximately first 15 minutes of resuscitation
Percentage of PPV Inflations With Inadequate Tidal Volume
Percentage of PPV inflations with inadequate tidal volume defined as Vte \<4 ml/kg in the first 15 minutes of resuscitation.
Time frame: approximately first 15 minutes of resuscitation
Percentage of Oxygen Saturation (SpO2) in the First 10 Minutes of Life
Median percentage of Oxygen saturation (SpO2) captured on the Respiratory Function Monitor between 3 and 10 minutes of life
Time frame: Between 3 and 10 minutes of life
Fraction of Inspired Oxygen (FiO2) Provided in the First 10 Minutes of Life
Median fraction of inspired oxygen (FiO2) provided to the infant between 3 and 10 minutes of life
Time frame: between 3 and 10 minutes of life
Total Duration With FiO2 of 100% Delivered in the First 10 Minutes of Life
Total duration of time where FiO2 of 100% is delivered to the patient in first 10 minutes of life will be calculated taking into consideration birth weight, tidal volume, respiratory rate, FiO2 and timing of stabilization.
Time frame: approximately first 10 minutes of life
Number of Participants Receiving Endotracheal Intubation in the Delivery Room
Number of Participants receiving Endotracheal Intubation in the delivery room from time of birth to admission to NICU
Time frame: from time of birth to admission to NICU
Number of Participants Requiring Inotropes for Circulatory Support
Number of participants requiring inotropes for circulatory support in the Neonatal Intensive Care Unit in the first 3 days after birth
Time frame: within the first 3 days after birth
Number of Participants With Pneumothorax
Number of participants with pneumothorax in the first 72 hours after birth reported by a radiologist masked to the intervention
Time frame: in the first 72 hours after birth
Number of Participants With Pulmonary Interstitial Emphysema
Number of participants with Pulmonary Interstitial Emphysema in the first 72 hours after birth reported by a radiologist masked to the intervention
Time frame: in the first 72 hours of life
Number of Participants With Abnormal Cranial Ultrasound Findings
Number of participants with abnormal cranial ultrasound findings (i) all intraventricular hemorrhage, (ii) severe - ie. Papile grade III and IV intraventricular hemorrhage, (iii) cystic periventricular leukomalacia through study completion, an average of 4 months
Time frame: through study completion, an average of 4 months
Duration of Endotracheal Ventilation
Duration of endotracheal (ET) ventilation days through study completion, an average of 4 months
Time frame: days through study completion, an average of 4 months
Duration of Non-invasive Ventilation
Duration of non-invasive ventilation, days through study completion, an average of 4 months
Time frame: days through study completion, an average of 4 months
Duration of Supplemental Oxygen Therapy
Duration of supplemental oxygen therapy days through study completion, an average of 4 months
Time frame: days through study completion, an average of 4 months
Total Duration of Assisted Ventilation
Total duration of assisted ventilation (ET, CPAP) in hours through study completion, an average of 4 months
Time frame: through study completion, an average of 4 months
Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia
Number of participants with a diagnosis of bronchopulmonary dysplasia (BPD) at 36 weeks corrected gestational age defined as the need for supplementary oxygen and/or any form respiratory support
Time frame: at 36 weeks corrected gestational age
Neonatal Mortality
Neonatal mortality from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first
Time frame: from time of birth until discharge from hospital, up to 44 weeks corrected gestational age
Composite Outcome of Death or BPD
Composite outcome of death or BPD. BPD assessed at corrected gestational age of 36 weeks; death assessed from time of birth until discharge, up to 44 weeks corrected gestational age
Time frame: BPD assessed at corrected gestational age of 36 weeks; death assessed from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first
Number of Participants With Retinopathy of Prematurity Requiring Treatment
Number of participants with Retinopathy of prematurity requiring treatment before hospital discharge, an average of 4 months
Time frame: before hospital discharge, an average of 4 months
Number of Participants With a Diagnosis of Necrotizing Enterocolitis
Number of participants with a diagnosis of Necrotizing enterocolitis grade 2 or more before hospital discharge, an average of 4 months
Time frame: before hospital discharge, an average of 4 months
Number of Participants Requiring Fluid Boluses for Circulatory Support
Number of participants requiring fluid boluses for circulatory support in the Neonatal Intensive Care Unit within the first 3 days of life
Time frame: within the first 3 days of life
Number of Participants With Endotracheal Intubation in the NICU
Number of Participants with Endotracheal Intubation in the NICU in the first 24 hours of life
Time frame: in the first 24 hours of life
Neonatal Mortality in the Delivery Room
Neonatal Mortality in the delivery room from time of birth until transfer to NICU
Time frame: from time of birth until transfer to NICU
Recruitment occurred between Oct 2013-May 2019 in 7 NICUs in 6 Countries (Netherlands, Australia, Germany, Spain, Italy, and the United States). IRBs at each site approved the study. At five of the seven non-US sites, deferred consent was endorsed for use when there was insufficient time for antenatal consent, or it was considered inappropriate.
| Milestone | RFM Visible | RFM Masked |
|---|---|---|
| Started | 204 | 206 |
| Completed | 138 | 150 |
| Not completed | 66 | 56 |
| Withdrew: Excluded post randomization | 66 | 56 |
To test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks gestation) after birth will increase the percentage of inflations performed with a predefined VTe "safe range" of 4 - 8 mls/kg.
| percentage of inflations | RFM Visible | RFM Masked |
|---|---|---|
| Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg | 30.2 (18.0 to 41.6) | 30.7 (15.8 to 43.4) |
Median percentage of oxygen saturation (SpO2) captured on the Respiratory Function Monitor in the first 5 minutes of life
| percentage of oxygen saturation | RFM Visible | RFM Masked |
|---|---|---|
| Percentage of Oxygen Saturation (SpO2) in the First 5 Minutes of Life | 59 (46 to 71) | 63 (52 to 72) |
Median Heart rate captured on the Respiratory Function Monitor between 3 and10 minutes of life
| beats per minute | RFM Visible | RFM Masked |
|---|---|---|
| Heart Rate in the First 10 Minutes of Life | 144 (130 to 156) | 143 (127 to 158) |
Percentage of time with significant mask leak (defined as \> 60%) during the duration of PPV ventilation per infant in the first 15 minutes of resuscitation.
| percentage of time | RFM Visible | RFM Masked |
|---|---|---|
| Percentage of Time With Mask Leak During PPV Ventilation | 17.4 (7.2 to 33.3) | 13.6 (3.7 to 32.1) |
Percentage of PPV inflations with airway obstruction in the first 15 minutes of resuscitation. Airway obstruction is defined as Vte \<1 mL/kg, with minimal mask leak (\<25%) during an inflation and flattening of the flow waves.
| percentage of inflations | RFM Visible | RFM Masked |
|---|---|---|
| Percentage of PPV Inflations With Airway Obstruction | 0 (0 to 0) | 0 (0 to 0) |
Percentage of PPV inflations with inadequate tidal volume defined as Vte \<4 ml/kg in the first 15 minutes of resuscitation.
| percentage of inflations | RFM Visible | RFM Masked |
|---|---|---|
| Percentage of PPV Inflations With Inadequate Tidal Volume | 40.7 (20.5 to 62.4) | 34.1 (18.5 to 52.6) |
Median percentage of Oxygen saturation (SpO2) captured on the Respiratory Function Monitor between 3 and 10 minutes of life
| percentage of oxygen saturation | RFM Visible | RFM Masked |
|---|---|---|
| Percentage of Oxygen Saturation (SpO2) in the First 10 Minutes of Life | 84 (74 to 89) | 85 (75 to 90) |
Median fraction of inspired oxygen (FiO2) provided to the infant between 3 and 10 minutes of life
| percentage fraction of inspired oxygen | RFM Visible | RFM Masked |
|---|---|---|
| Fraction of Inspired Oxygen (FiO2) Provided in the First 10 Minutes of Life | 51 (36 to 74) | 49 (36 to 69) |
Total duration of time where FiO2 of 100% is delivered to the patient in first 10 minutes of life will be calculated taking into consideration birth weight, tidal volume, respiratory rate, FiO2 and timing of stabilization.
| percentage of time | RFM Visible | RFM Masked |
|---|---|---|
| Total Duration With FiO2 of 100% Delivered in the First 10 Minutes of Life | 0 (0 to 13.2) | 0 (0 to 11.9) |
Number of Participants receiving Endotracheal Intubation in the delivery room from time of birth to admission to NICU
| Participants | RFM Visible | RFM Masked |
|---|---|---|
| Number of Participants Receiving Endotracheal Intubation in the Delivery Room | 47 | 54 |
Number of participants requiring inotropes for circulatory support in the Neonatal Intensive Care Unit in the first 3 days after birth
| Participants | RFM Visible | RFM Masked |
|---|---|---|
| Number of Participants Requiring Inotropes for Circulatory Support | 22 | 32 |
Number of participants with pneumothorax in the first 72 hours after birth reported by a radiologist masked to the intervention
| Participants | RFM Visible | RFM Masked |
|---|---|---|
| Number of Participants With Pneumothorax | 6 | 11 |
Number of participants with Pulmonary Interstitial Emphysema in the first 72 hours after birth reported by a radiologist masked to the intervention
| Participants | RFM Visible | RFM Masked |
|---|---|---|
| Number of Participants With Pulmonary Interstitial Emphysema | 12 | 7 |
Number of participants with abnormal cranial ultrasound findings (i) all intraventricular hemorrhage, (ii) severe - ie. Papile grade III and IV intraventricular hemorrhage, (iii) cystic periventricular leukomalacia through study completion, an average of 4 months
| Participants | RFM Visible | RFM Masked |
|---|---|---|
| Number of Participants With Abnormal Cranial Ultrasound Findings | 36 | 58 |
Duration of endotracheal (ET) ventilation days through study completion, an average of 4 months
| days | RFM Visible | RFM Masked |
|---|---|---|
| Duration of Endotracheal Ventilation | 7 (1 to 20) | 6 (1 to 17) |
Duration of non-invasive ventilation, days through study completion, an average of 4 months
| days | RFM Visible | RFM Masked |
|---|---|---|
| Duration of Non-invasive Ventilation | 41 (29 to 56) | 37 (16 to 55) |
Duration of supplemental oxygen therapy days through study completion, an average of 4 months
| days | RFM Visible | RFM Masked |
|---|---|---|
| Duration of Supplemental Oxygen Therapy | 43 (15 to 77) | 35 (8 to 75) |
Total duration of assisted ventilation (ET, CPAP) in hours through study completion, an average of 4 months
No measurements were reported for this outcome.
Number of participants with a diagnosis of bronchopulmonary dysplasia (BPD) at 36 weeks corrected gestational age defined as the need for supplementary oxygen and/or any form respiratory support
| Participants | RFM Visible | RFM Masked |
|---|---|---|
| Mild | 32 | 26 |
| Moderate | 8 | 10 |
| Severe | 30 | 41 |
| No BPD | 68 | 72 |
Neonatal mortality from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first
| Participants | RFM Visible | RFM Masked |
|---|---|---|
| Neonatal Mortality | 21 | 24 |
Composite outcome of death or BPD. BPD assessed at corrected gestational age of 36 weeks; death assessed from time of birth until discharge, up to 44 weeks corrected gestational age
| Participants | RFM Visible | RFM Masked |
|---|---|---|
| Composite Outcome of Death or BPD | 84 | 96 |
Number of participants with Retinopathy of prematurity requiring treatment before hospital discharge, an average of 4 months
| Participants | RFM Visible | RFM Masked |
|---|---|---|
| Number of Participants With Retinopathy of Prematurity Requiring Treatment | 9 | 15 |
Number of participants with a diagnosis of Necrotizing enterocolitis grade 2 or more before hospital discharge, an average of 4 months
| Participants | RFM Visible | RFM Masked |
|---|---|---|
| Number of Participants With a Diagnosis of Necrotizing Enterocolitis | 17 | 13 |
Number of participants requiring fluid boluses for circulatory support in the Neonatal Intensive Care Unit within the first 3 days of life
| Participants | RFM Visible | RFM Masked |
|---|---|---|
| Number of Participants Requiring Fluid Boluses for Circulatory Support | 36 | 45 |
Number of Participants with Endotracheal Intubation in the NICU in the first 24 hours of life
| Participants | RFM Visible | RFM Masked |
|---|---|---|
| Number of Participants With Endotracheal Intubation in the NICU | 26 | 30 |
Neonatal Mortality in the delivery room from time of birth until transfer to NICU
| Participants | RFM Visible | RFM Masked |
|---|---|---|
| Neonatal Mortality in the Delivery Room | 0 | 1 |
Collected over Adverse events were monitored from the time of birth (in the delivery room) to the time of transfer to the Neonatal Intensive Care Unit. All cause mortality was documented from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RFM Visible | 21/138 (15.2%) | 3/138 (2.2%) | 0/138 (0%) |
| RFM Masked | 24/150 (16%) | 4/150 (2.7%) | 0/150 (0%) |
| Event | RFM Visible | RFM Masked |
|---|---|---|
| Chest CompressionsRespiratory, thoracic and mediastinal disorders | 2/138 | 3/150 |
| AdrenalineRespiratory, thoracic and mediastinal disorders | 1/138 | 1/150 |
| Age, Customized(weeks) | RFM Visible | RFM Masked | Total |
|---|---|---|---|
| Gestational age in weeks | 26 (25 to 27) | 26 (25 to 27) | 26 (25 to 27) |
| Sex: Female, Male(Participants) | RFM Visible | RFM Masked | Total |
|---|---|---|---|
| Female | 64 | 67 | 131 |
| Male | 74 | 83 | 157 |
| Race and Ethnicity Not Collected(Participants) | RFM Visible | RFM Masked | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | RFM Visible | RFM Masked | Total |
|---|---|---|---|
| United States | 9 | 12 | 21 |
| Netherlands | 42 | 54 | 96 |
| Italy | 31 | 27 | 58 |
| Australia | 36 | 38 | 74 |
| Spain | 13 | 14 | 27 |
| Germany | 7 | 5 | 12 |
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