标题：The SURV1VE trial—sustained inflation and chest compression versus 3:1 chest compression-to-ventilation ratio during cardiopulmonary resuscitation of asphyxiated newborns: study protocol for a cluster randomized controlled trial
摘要：Background: 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. 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.
Methods: This 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.
Discussion: Morbidity 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.
