Neonatal Prematurity, Positive-Pressure Respiration, Resuscitation
Conditions
Keywords
Resuscitation, Neonatal Prematurity, Positive-Pressure Ventilation, Respiratory Function Monitor
Brief summary
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.
Detailed description
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.
Interventions
DEVICENew Life Box Respiratory Function Monitor
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.
Sponsors
Leiden University Medical Center
Royal Women's Hospital in Melbourne, Australia
Maternal & Children's University Hospital, Valencia, Spain
Vittore Buzzi Children's Hospital
Karolinska University Hospital
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
The waveform data and videos captured during the study intervention will be centralized to Leiden University Medical Center. The team at Leiden University Medical Center assessing the outcomes will be will be blinded to the randomization allocation of the infant.
Intervention model description
Eligible infants are either randomized to the intervention, where the clinical team will be able to directly observe the monitor or randomized to the RFM-masked display arm, where they will only see a black screen.
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 28 Weeks
Healthy volunteers
No
Inclusion criteria
* Gestational age (GA) 24 - 27 6/7 weeks at birth, by best obstetrical * Receive positive pressure ventilation during delivery room resuscitation
Exclusion criteria
* Known major anomalies including that may affect measured cardiorespiratory parameters: congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease, pulmonary hypoplasia * RFM not available during resuscitation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg | the first 15 minutes of resuscitation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate in the First 10 Minutes of Life | between 3 and 10 minutes of life | Median Heart rate captured on the Respiratory Function Monitor between 3 and10 minutes of life |
| Percentage of Time With Mask Leak During PPV Ventilation | approximately first 15 minutes of resuscitation | 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 Oxygen Saturation (SpO2) in the First 10 Minutes of Life | Between 3 and 10 minutes of life | Median percentage of Oxygen saturation (SpO2) captured on the Respiratory Function Monitor between 3 and 10 minutes of life |
| Percentage of PPV Inflations With Airway Obstruction | approximately first 15 minutes of resuscitation | 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 PPV Inflations With Inadequate Tidal Volume | approximately first 15 minutes of resuscitation | Percentage of PPV inflations with inadequate tidal volume defined as Vte \<4 ml/kg in the first 15 minutes of resuscitation. |
| Fraction of Inspired Oxygen (FiO2) Provided in the First 10 Minutes of Life | between 3 and 10 minutes of life | Median fraction of inspired oxygen (FiO2) provided to the infant between 3 and 10 minutes of life |
| Total Duration With FiO2 of 100% Delivered in the First 10 Minutes of Life | approximately 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. |
| Number of Participants Receiving Endotracheal Intubation in the Delivery Room | from time of birth to admission to NICU | Number of Participants receiving Endotracheal Intubation in the delivery room from time of birth to admission to NICU |
| Number of Participants Requiring Inotropes for Circulatory Support | within the first 3 days after birth | Number of participants requiring inotropes for circulatory support in the Neonatal Intensive Care Unit in the first 3 days after birth |
| Number of Participants With Pneumothorax | in the first 72 hours after birth | Number of participants with pneumothorax in the first 72 hours after birth reported by a radiologist masked to the intervention |
| Number of Participants With Pulmonary Interstitial Emphysema | in the first 72 hours of life | Number of participants with Pulmonary Interstitial Emphysema in the first 72 hours after birth reported by a radiologist masked to the intervention |
| Number of Participants With Abnormal Cranial Ultrasound Findings | through study completion, an average of 4 months | 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 |
| Percentage of Oxygen Saturation (SpO2) in the First 5 Minutes of Life | approximately first 5 minutes of life | Median percentage of oxygen saturation (SpO2) captured on the Respiratory Function Monitor in the first 5 minutes of life |
| Duration of Non-invasive Ventilation | days through study completion, an average of 4 months | Duration of non-invasive ventilation, days through study completion, an average of 4 months |
| Duration of Supplemental Oxygen Therapy | days through study completion, an average of 4 months | Duration of supplemental oxygen therapy days through study completion, an average of 4 months |
| Total Duration of Assisted Ventilation | through study completion, an average of 4 months | Total duration of assisted ventilation (ET, CPAP) in hours through study completion, an average of 4 months |
| Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia | at 36 weeks corrected gestational age | 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 |
| Neonatal Mortality | from time of birth until discharge from hospital, up to 44 weeks corrected gestational age | Neonatal mortality from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first |
| Composite Outcome of Death or BPD | 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 | 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 |
| Number of Participants With Retinopathy of Prematurity Requiring Treatment | before hospital discharge, an average of 4 months | Number of participants with Retinopathy of prematurity requiring treatment before hospital discharge, an average of 4 months |
| Number of Participants With a Diagnosis of Necrotizing Enterocolitis | before hospital discharge, an average of 4 months | Number of participants with a diagnosis of Necrotizing enterocolitis grade 2 or more before hospital discharge, an average of 4 months |
| Number of Participants Requiring Fluid Boluses for Circulatory Support | within the first 3 days of life | Number of participants requiring fluid boluses for circulatory support in the Neonatal Intensive Care Unit within the first 3 days of life |
| Number of Participants With Endotracheal Intubation in the NICU | in the first 24 hours of life | Number of Participants with Endotracheal Intubation in the NICU in the first 24 hours of life |
| Neonatal Mortality in the Delivery Room | from time of birth until transfer to NICU | Neonatal Mortality in the delivery room from time of birth until transfer to NICU |
| Duration of Endotracheal Ventilation | days through study completion, an average of 4 months | Duration of endotracheal (ET) ventilation days through study completion, an average of 4 months |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Infants with antenatal enrollment into the trial were excluded from randomization if their delivery occurred outside of the gestational age eligibility window.Post-randomization exclusion occurred if postnatal consent was not obtained, no IPPV delivered, equipment failure, or a congenital anomaly was discovered.
Participants by arm
| Arm | Count |
|---|---|
| RFM Visible 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.
New Life Box Respiratory Function Monitor: 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. | 138 |
| RFM Masked 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. | 150 |
| Total | 288 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Excluded Post Randomization | 66 | 56 |
Baseline characteristics
| Characteristic | RFM Visible | RFM Masked | Total |
|---|---|---|---|
| Age, Customized Gestational age in weeks | 26 weeks | 26 weeks | 26 weeks |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Australia | 36 participants | 38 participants | 74 participants |
| Region of Enrollment Germany | 7 participants | 5 participants | 12 participants |
| Region of Enrollment Italy | 31 participants | 27 participants | 58 participants |
| Region of Enrollment Netherlands | 42 participants | 54 participants | 96 participants |
| Region of Enrollment Spain | 13 participants | 14 participants | 27 participants |
| Region of Enrollment United States | 9 participants | 12 participants | 21 participants |
| Sex: Female, Male Female | 64 Participants | 67 Participants | 131 Participants |
| Sex: Female, Male Male | 74 Participants | 83 Participants | 157 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 21 / 138 | 24 / 150 |
| other Total, other adverse events | 0 / 138 | 0 / 150 |
| serious Total, serious adverse events | 3 / 138 | 4 / 150 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RFM Visible | Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg | 30.2 percentage of inflations |
| RFM Masked | Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg | 30.7 percentage of inflations |
p-value: 0.896Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RFM Visible | Composite Outcome of Death or BPD | 84 Participants |
| RFM Masked | Composite Outcome of Death or BPD | 96 Participants |
p-value: 0.52495% CI: [0.834, 1.186]Chi-squared
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RFM Visible | Duration of Endotracheal Ventilation | 7 days |
| RFM Masked | Duration of Endotracheal Ventilation | 6 days |
p-value: 0.585Wilcoxon (Mann-Whitney)
Secondary
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
Population: 1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RFM Visible | Duration of Non-invasive Ventilation | 41 days |
| RFM Masked | Duration of Non-invasive Ventilation | 37 days |
p-value: 0.342Wilcoxon (Mann-Whitney)
Secondary
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
Population: 1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RFM Visible | Duration of Supplemental Oxygen Therapy | 43 days |
| RFM Masked | Duration of Supplemental Oxygen Therapy | 35 days |
p-value: 0.431Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RFM Visible | Fraction of Inspired Oxygen (FiO2) Provided in the First 10 Minutes of Life | 51 percentage fraction of inspired oxygen |
| RFM Masked | Fraction of Inspired Oxygen (FiO2) Provided in the First 10 Minutes of Life | 49 percentage fraction of inspired oxygen |
p-value: 0.434Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RFM Visible | Heart Rate in the First 10 Minutes of Life | 144 beats per minute |
| RFM Masked | Heart Rate in the First 10 Minutes of Life | 143 beats per minute |
p-value: 0.847Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RFM Visible | Neonatal Mortality | 21 Participants |
| RFM Masked | Neonatal Mortality | 24 Participants |
p-value: 0.85595% CI: [0.555, 1.629]Chi-squared
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RFM Visible | Neonatal Mortality in the Delivery Room | 0 Participants |
| RFM Masked | Neonatal Mortality in the Delivery Room | 1 Participants |
p-value: 195% CI: [0.99, 1.02]Chi-squared
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RFM Visible | Number of Participants Receiving Endotracheal Intubation in the Delivery Room | 47 Participants |
| RFM Masked | Number of Participants Receiving Endotracheal Intubation in the Delivery Room | 54 Participants |
p-value: 0.699Chi-squared
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RFM Visible | Number of Participants Requiring Fluid Boluses for Circulatory Support | 36 Participants |
| RFM Masked | Number of Participants Requiring Fluid Boluses for Circulatory Support | 45 Participants |
p-value: 0.486Chi-squared
Secondary
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
Population: 1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RFM Visible | Number of Participants Requiring Inotropes for Circulatory Support | 22 Participants |
| RFM Masked | Number of Participants Requiring Inotropes for Circulatory Support | 32 Participants |
p-value: 0.231Chi-squared
Secondary
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
Population: 1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RFM Visible | Number of Participants With Abnormal Cranial Ultrasound Findings | 36 Participants |
| RFM Masked | Number of Participants With Abnormal Cranial Ultrasound Findings | 58 Participants |
p-value: 0.02495% CI: [0.474, 0.947]Chi-squared
Secondary
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
Population: 1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RFM Visible | Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia | Moderate | 8 Participants |
| RFM Visible | Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia | Mild | 32 Participants |
| RFM Visible | Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia | Severe | 30 Participants |
| RFM Visible | Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia | No BPD | 68 Participants |
| RFM Masked | Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia | No BPD | 72 Participants |
| RFM Masked | Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia | Moderate | 10 Participants |
| RFM Masked | Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia | Severe | 41 Participants |
| RFM Masked | Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia | Mild | 26 Participants |
p-value: 0.51895% CI: [0.854, 1.313]Chi-squared
Secondary
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
Population: 1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RFM Visible | Number of Participants With a Diagnosis of Necrotizing Enterocolitis | 17 Participants |
| RFM Masked | Number of Participants With a Diagnosis of Necrotizing Enterocolitis | 13 Participants |
p-value: 0.33995% CI: [0.703, 2.76]Chi-squared
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RFM Visible | Number of Participants With Endotracheal Intubation in the NICU | 26 Participants |
| RFM Masked | Number of Participants With Endotracheal Intubation in the NICU | 30 Participants |
p-value: 0.655Chi-squared
Secondary
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
Population: 1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RFM Visible | Number of Participants With Pneumothorax | 6 Participants |
| RFM Masked | Number of Participants With Pneumothorax | 11 Participants |
p-value: 0.28395% CI: [0.225, 1.561]Chi-squared
Secondary
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
Population: 1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RFM Visible | Number of Participants With Pulmonary Interstitial Emphysema | 12 Participants |
| RFM Masked | Number of Participants With Pulmonary Interstitial Emphysema | 7 Participants |
p-value: 0.16895% CI: [0.756, 4.599]Chi-squared
Secondary
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
Population: 1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RFM Visible | Number of Participants With Retinopathy of Prematurity Requiring Treatment | 9 Participants |
| RFM Masked | Number of Participants With Retinopathy of Prematurity Requiring Treatment | 15 Participants |
p-value: 0.2895% CI: [0.294, 1.434]Chi-squared
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RFM Visible | Percentage of Oxygen Saturation (SpO2) in the First 10 Minutes of Life | 84 percentage of oxygen saturation |
| RFM Masked | Percentage of Oxygen Saturation (SpO2) in the First 10 Minutes of Life | 85 percentage of oxygen saturation |
p-value: 0.656Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RFM Visible | Percentage of Oxygen Saturation (SpO2) in the First 5 Minutes of Life | 59 percentage of oxygen saturation |
| RFM Masked | Percentage of Oxygen Saturation (SpO2) in the First 5 Minutes of Life | 63 percentage of oxygen saturation |
p-value: 0.107Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RFM Visible | Percentage of PPV Inflations With Airway Obstruction | 0 percentage of inflations |
| RFM Masked | Percentage of PPV Inflations With Airway Obstruction | 0 percentage of inflations |
p-value: 0.346Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RFM Visible | Percentage of PPV Inflations With Inadequate Tidal Volume | 40.7 percentage of inflations |
| RFM Masked | Percentage of PPV Inflations With Inadequate Tidal Volume | 34.1 percentage of inflations |
p-value: 0.094Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RFM Visible | Percentage of Time With Mask Leak During PPV Ventilation | 17.4 percentage of time |
| RFM Masked | Percentage of Time With Mask Leak During PPV Ventilation | 13.6 percentage of time |
p-value: 0.126Wilcoxon (Mann-Whitney)
Secondary
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
Population: Outcome measure was not analyzed as the way the data was collected did not allow for a total calculation of all assisted ventilation. (Data collected at all centers provided the data in days (defined as minimum of 6 hours per day) separately for mechanical and non-invasive ventilation, therefore even a total estimation in days may not be representative).
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RFM Visible | Total Duration With FiO2 of 100% Delivered in the First 10 Minutes of Life | 0 percentage of time |
| RFM Masked | Total Duration With FiO2 of 100% Delivered in the First 10 Minutes of Life | 0 percentage of time |
p-value: 0.903Wilcoxon (Mann-Whitney)