Monitoring Neonatal Resuscitation Trial

Not Applicable

Completed

• Conditions: Resuscitation; Neonatal Prematurity; Positive-Pressure Respiration
• Interventions: Device: New Life Box Respiratory Function Monitor

• Registration Number: NCT03256578
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study Start: 2017-02-20
• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-22
• Primary Completion: 2019-05-17
• Disposition First Submitted: 2020-02-18
• Results First Submitted: 2020-11-02
• Results First Submitted QC: 2020-12-23
• Disposition First Submitted QC: 2020-12-23
• Results First Posted: 2021-01-19
• Disposition First Posted: 2021-01-19
• Study Completion: 2021-09-20
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

• Gestational age (GA) 24 - 27 6/7 weeks at birth, by best obstetrical
• Receive positive pressure ventilation during delivery room resuscitation

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFM visible	New Life Box Respiratory Function Monitor	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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 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
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
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
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.
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
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
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
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
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.
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 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 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 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
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 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
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
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
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 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

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States