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

Brief Summary

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.

Primary Outcomes

Secondary Outcomes

• Neonatal Mortality in the Delivery Room(from time of birth until transfer to NICU)
• Fraction of Inspired Oxygen (FiO2) Provided in the First 10 Minutes of Life(between 3 and 10 minutes of life)
• Heart Rate in the First 10 Minutes of Life(between 3 and 10 minutes of life)
• 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)
• 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)
• Percentage of Time With Mask Leak During PPV Ventilation(approximately first 15 minutes of resuscitation)
• Number of Participants With Pulmonary Interstitial Emphysema(in the first 72 hours of life)
• 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)
• Percentage of PPV Inflations With Inadequate Tidal Volume(approximately 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)
• Number of Participants Requiring Inotropes for Circulatory Support(within the first 3 days after birth)
• Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia(at 36 weeks corrected gestational age)
• Neonatal Mortality(from time of birth until discharge from hospital, up to 44 weeks corrected gestational age)
• 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)
• 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)
• Percentage of PPV Inflations With Airway Obstruction(approximately first 15 minutes of resuscitation)
• Percentage of Oxygen Saturation (SpO2) in the First 10 Minutes of Life(Between 3 and 10 minutes of life)
• Number of Participants With Abnormal Cranial Ultrasound Findings(through study completion, an average of 4 months)
• Duration of Endotracheal Ventilation(days through study completion, an average of 4 months)
• Total Duration of Assisted Ventilation(through study completion, an average of 4 months)
• Number of Participants With Endotracheal Intubation in the NICU(in the first 24 hours of life)