Abstract
BackgroundThe need for cardiopulmonary resuscitation (CPR) is often unexpected, and the infrequent use of CPR in the delivery room (DR) limits the opportunity to perform rigorous clinical studies to determine the best method for delivering chest compression (CC) to newborn infants. The current neonatal resuscitation guidelines recommend using a coordinated 3:1 compression-to-ventilation (C:V) ratio (CC at a rate of 90/min and ventilations at a rate of 30/min). In comparison, providing CC during a sustained inflation (SI) (CC + SI) significantly improved hemodynamics, minute ventilation, and time to return of spontaneous circulation (ROSC) compared to 3:1 C:V ratio in asphyxiated piglets. Similarly, a small pilot trial in newborn infants showed similar results. Until now no study has examined different CC techniques during neonatal resuscitation in asphyxiated newborn infants in the DR. To date, no trial has been performed to directly compare CC + SI and 3:1 C:V ratio in the DR during CPR of asphyxiated newborn infants.MethodsThis is a large, international, multi-center, prospective, unblinded, cluster randomized controlled trial in asphyxiated newborn infants at birth. All term and preterm infants > 28+ 0 by best obstetrical estimate who require CPR at birth due to bradycardia (< 60/min) or asystole are eligible. The primary outcome of this study is to compare the time to ROSC in infants born > 28+ 0 weeks’ gestational age with bradycardia (< 60/min) or asystole immediately after birth who receive either CC + SI or 3:1 C:V ratio as the CPR strategy.DiscussionMorbidity and mortality rates are extremely high for newborns requiring CC. We believe the combination of simultaneous CC and SI during CPR has the potential to significantly improve ROSC and survival. In addition, we believe that CC + SI might improve respiratory and hemodynamic parameters and potentially minimize morbidity and mortality in newborn infants. In addition, this will be the first randomized controlled trial to examine CC in the newborn period.Trial registrationClinicalTrials.gov, NCT02858583. Registered on 8 August 2016
Highlights
The need for cardiopulmonary resuscitation (CPR) is often unexpected, and the infrequent use of CPR in the delivery room (DR) limits the opportunity to perform rigorous clinical studies to determine the best method for delivering chest compression (CC) to newborn infants
CC + sustained inflation (SI) 90/min compared to 3:1 C:V ratio in a porcine model of neonatal resuscitation reported a significant reduction in median (interquartile range (IQR)) time to return of spontaneous circulation (ROSC), 34 (28–156) s versus 210 (72–300) s (p = 0.05), and less use of supplementary oxygen during CPR (p = 0.03) and epinephrine (p = 0.32) in the CC + SI 90/min group [24]
Secondary outcome measures Secondary outcomes among others will include physiological parameters and respiratory function during CPR, neonatal mortality and morbidities, e.g., brain injury (reported either via magnetic resonance imaging (MRI) or head ultrasound), changes in regional cerebral oxygen saturation using near-infrared spectroscopy (NIRS) monitoring started in the DR and discontinued when clinical stabilization is achieved, results of amplitude integrated electroencephalography monitoring until normalization of background patterns and occurrence of sleep-wake cycling, DR interventions, neonatal intensive care unit (NICU) admission temperature, use of therapeutic cooling, use of mechanical ventilation, pneumothorax, use of inotropes, infection/sepsis, intraventricular hemorrhage, necrotizing enterocolitis, bronchopulmonary dysplasia, retinopathy of prematurity, and long-term neurodevelopmental outcomes
Summary
The need for cardiopulmonary resuscitation (CPR) is often unexpected, and the infrequent use of CPR in the delivery room (DR) limits the opportunity to perform rigorous clinical studies to determine the best method for delivering chest compression (CC) to newborn infants. A further randomized animal trial compared CC + SI using a CC rate of 90/min versus 120/min and reported similar time to ROSC, survival rates, and respiratory parameters during CPR [22].
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