Trial Outcomes & Findings for Monitoring Neonatal Resuscitation Trial (NCT NCT03256578)

NCT ID: NCT03256578

Last Updated: 2021-11-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 288 participants
• Primary outcome timeframe: the first 15 minutes of resuscitation
• Results posted on: 2021-11-22

Participant Flow

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.

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.

Participant milestones

Measure	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.	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.
Overall Study STARTED	204	206
Overall Study COMPLETED	138	150
Overall Study NOT COMPLETED	66	56

Reasons for withdrawal

Measure	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.	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.
Overall Study Excluded Post Randomization	66	56

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=150 Participants 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.	Total n=288 Participants Total of all reporting groups
Age, Customized Gestational age in weeks	26 weeks n=138 Participants	26 weeks n=150 Participants	26 weeks n=288 Participants
Sex: Female, Male Female	64 Participants n=138 Participants	67 Participants n=150 Participants	131 Participants n=288 Participants
Sex: Female, Male Male	74 Participants n=138 Participants	83 Participants n=150 Participants	157 Participants n=288 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	9 participants n=138 Participants	12 participants n=150 Participants	21 participants n=288 Participants
Region of Enrollment Netherlands	42 participants n=138 Participants	54 participants n=150 Participants	96 participants n=288 Participants
Region of Enrollment Italy	31 participants n=138 Participants	27 participants n=150 Participants	58 participants n=288 Participants
Region of Enrollment Australia	36 participants n=138 Participants	38 participants n=150 Participants	74 participants n=288 Participants
Region of Enrollment Spain	13 participants n=138 Participants	14 participants n=150 Participants	27 participants n=288 Participants
Region of Enrollment Germany	7 participants n=138 Participants	5 participants n=150 Participants	12 participants n=288 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	RFM Visible n=25432 Total inflations 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.	RFM Masked n=25920 Total inflations 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.
Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg	30.2 percentage of inflations Interval 18.0 to 41.6	30.7 percentage of inflations Interval 15.8 to 43.4

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=150 Participants 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.
Percentage of Oxygen Saturation (SpO2) in the First 5 Minutes of Life	59 percentage of oxygen saturation Interval 46.0 to 71.0	63 percentage of oxygen saturation Interval 52.0 to 72.0

SECONDARY outcome

Timeframe: between 3 and 10 minutes of life

Median Heart rate captured on the Respiratory Function Monitor between 3 and10 minutes of life

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=150 Participants 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.
Heart Rate in the First 10 Minutes of Life	144 beats per minute Interval 130.0 to 156.0	143 beats per minute Interval 127.0 to 158.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=150 Participants 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.
Percentage of Time With Mask Leak During PPV Ventilation	17.4 percentage of time Interval 7.2 to 33.3	13.6 percentage of time Interval 3.7 to 32.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=150 Participants 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.
Percentage of PPV Inflations With Airway Obstruction	0 percentage of inflations Interval 0.0 to 0.0	0 percentage of inflations Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=150 Participants 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.
Percentage of PPV Inflations With Inadequate Tidal Volume	40.7 percentage of inflations Interval 20.5 to 62.4	34.1 percentage of inflations Interval 18.5 to 52.6

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=150 Participants 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.
Percentage of Oxygen Saturation (SpO2) in the First 10 Minutes of Life	84 percentage of oxygen saturation Interval 74.0 to 89.0	85 percentage of oxygen saturation Interval 75.0 to 90.0

SECONDARY outcome

Timeframe: between 3 and 10 minutes of life

Median fraction of inspired oxygen (FiO2) provided to the infant between 3 and 10 minutes of life

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=150 Participants 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.
Fraction of Inspired Oxygen (FiO2) Provided in the First 10 Minutes of Life	51 percentage fraction of inspired oxygen Interval 36.0 to 74.0	49 percentage fraction of inspired oxygen Interval 36.0 to 69.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=150 Participants 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.
Total Duration With FiO2 of 100% Delivered in the First 10 Minutes of Life	0 percentage of time Interval 0.0 to 13.2	0 percentage of time Interval 0.0 to 11.9

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=150 Participants 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.
Number of Participants Receiving Endotracheal Intubation in the Delivery Room	47 Participants	54 Participants

SECONDARY outcome

Timeframe: 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.

Number of participants requiring inotropes for circulatory support in the Neonatal Intensive Care Unit in the first 3 days after birth

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=149 Participants 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.
Number of Participants Requiring Inotropes for Circulatory Support	22 Participants	32 Participants

SECONDARY outcome

Timeframe: 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.

Number of participants with pneumothorax in the first 72 hours after birth reported by a radiologist masked to the intervention

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=149 Participants 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.
Number of Participants With Pneumothorax	6 Participants	11 Participants

SECONDARY outcome

Timeframe: 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.

Number of participants with Pulmonary Interstitial Emphysema in the first 72 hours after birth reported by a radiologist masked to the intervention

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=149 Participants 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.
Number of Participants With Pulmonary Interstitial Emphysema	12 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=149 Participants 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.
Number of Participants With Abnormal Cranial Ultrasound Findings	36 Participants	58 Participants

SECONDARY outcome

Timeframe: days through study completion, an average of 4 months

Duration of endotracheal (ET) ventilation days through study completion, an average of 4 months

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=150 Participants 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.
Duration of Endotracheal Ventilation	7 days Interval 1.0 to 20.0	6 days Interval 1.0 to 17.0

SECONDARY outcome

Timeframe: 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.

Duration of non-invasive ventilation, days through study completion, an average of 4 months

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=149 Participants 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.
Duration of Non-invasive Ventilation	41 days Interval 29.0 to 56.0	37 days Interval 16.0 to 55.0

SECONDARY outcome

Timeframe: 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.

Duration of supplemental oxygen therapy days through study completion, an average of 4 months

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=149 Participants 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.
Duration of Supplemental Oxygen Therapy	43 days Interval 15.0 to 77.0	35 days Interval 8.0 to 75.0

SECONDARY outcome

Timeframe: 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).

Total duration of assisted ventilation (ET, CPAP) in hours through study completion, an average of 4 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=149 Participants 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.
Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia Mild	32 Participants	26 Participants
Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia Moderate	8 Participants	10 Participants
Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia Severe	30 Participants	41 Participants
Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia No BPD	68 Participants	72 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=150 Participants 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.
Neonatal Mortality	21 Participants	24 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=150 Participants 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.
Composite Outcome of Death or BPD	84 Participants	96 Participants

SECONDARY outcome

Timeframe: 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.

Number of participants with Retinopathy of prematurity requiring treatment before hospital discharge, an average of 4 months

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=149 Participants 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.
Number of Participants With Retinopathy of Prematurity Requiring Treatment	9 Participants	15 Participants

SECONDARY outcome

Timeframe: 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.

Number of participants with a diagnosis of Necrotizing enterocolitis grade 2 or more before hospital discharge, an average of 4 months

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=149 Participants 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.
Number of Participants With a Diagnosis of Necrotizing Enterocolitis	17 Participants	13 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=149 Participants 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.
Number of Participants Requiring Fluid Boluses for Circulatory Support	36 Participants	45 Participants

SECONDARY outcome

Timeframe: in the first 24 hours of life

Number of Participants with Endotracheal Intubation in the NICU in the first 24 hours of life

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=150 Participants 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.
Number of Participants With Endotracheal Intubation in the NICU	26 Participants	30 Participants

SECONDARY outcome

Timeframe: from time of birth until transfer to NICU

Neonatal Mortality in the delivery room from time of birth until transfer to NICU

Outcome measures

Measure	RFM Visible n=138 Participants 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.	RFM Masked n=150 Participants 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.
Neonatal Mortality in the Delivery Room	0 Participants	1 Participants

Adverse Events

RFM Visible

Serious events: 3 serious events

Other events: 0 other events

Deaths: 21 deaths

RFM Masked

Serious events: 4 serious events

Other events: 0 other events

Deaths: 24 deaths

Serious adverse events

Measure	RFM Visible n=138 participants at risk 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.	RFM Masked n=150 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Chest Compressions	1.4% 2/138 • 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. Need for positive pressure after birth is an inclusion criterion for this study, therefore respiratory failure requiring PPV or endotracheal intubation after birth was not considered an adverse event.	2.0% 3/150 • 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. Need for positive pressure after birth is an inclusion criterion for this study, therefore respiratory failure requiring PPV or endotracheal intubation after birth was not considered an adverse event.
Respiratory, thoracic and mediastinal disorders Adrenaline	0.72% 1/138 • 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. Need for positive pressure after birth is an inclusion criterion for this study, therefore respiratory failure requiring PPV or endotracheal intubation after birth was not considered an adverse event.	0.67% 1/150 • 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. Need for positive pressure after birth is an inclusion criterion for this study, therefore respiratory failure requiring PPV or endotracheal intubation after birth was not considered an adverse event.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Arjan te Pas

Leiden University Medical Center

Phone: +31 71 5265839

Email: a.b.te_pas@lumc.nl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60