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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
288
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.
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
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
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
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
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
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
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.
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Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
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
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
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
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
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