Monitoring Neonatal Resuscitation Trial

Study Overview
=================
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.

Official Title
-----------------
A Multi-center Randomized Controlled Trial of Respiratory Function Monitoring During Stabilization of Preterm Infants at Birth

Conditions
-----------------
Resuscitation, Neonatal Prematurity, Positive-Pressure Respiration

Intervention / Treatment
-----------------
* Device: New Life Box Respiratory Function Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 24 Weeks
Maximum Age: 28 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RFM visible<br>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<br>* 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.<br>|
| No Intervention: RFM masked<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | the first 15 minutes of resuscitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 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. | 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. | 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 | 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 | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | from time of birth until transfer to NICU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resuscitation, Neonatal Prematurity, Positive-Pressure Ventilation, Respiratory Function Monitor