SURV1VE-Trial - Sustained Inflation and Chest Compression Versus 3:1 Chest Compression to Ventilation Ratio During Cardiopulmonary Resuscitation of Asphyxiated Newborns: A Randomized Controlled Trial

Background The majority of newborn infants successfully make the transition from fetal to neonatal life without any help. However, an estimated 10% of newborns need help to establish effective ventilation, which remains the most critical step of neonatal resuscitation. Fortunately, the need for chest compression (CC) or medications in the delivery room (DR) is rare. Although, only about 0.1% of term infants and up to 15% of preterm infants receive these interventions, this will result in approximately 1 million newborn deaths annually worldwide. A recent cohort study at a level III center with a trained resuscitation team showed that only 6 per 10,000 infants received epinephrine. However, the same study showed that those infants who received epinephrine during resuscitation had a high incidence of mortality (41%) and short-term neurologic morbidity (57% hypoxic-ischemic encephalopathy and seizures)4. A recent review of newborns who received prolonged CC and epinephrine but had no signs of life at 10 minutes following birth noted 83% mortality, with 93% of survivors suffering moderate-to-severe disability. The poor prognosis associated with receiving CC alone or with medications in the DR raises questions as to whether improved cardiopulmonary resuscitation (CPR) methods specifically tailored to the newborn could improve outcomes.

The inability to predict which newborns need CPR, and the infrequent use of CPR in the DR have limited neonatologists' ability to perform rigorous clinical studies to determine the best method for delivering CC to newborn infants. The main cause of cardiovascular collapse in most newborns is asphyxia, which makes newborn infants distinctively different to the adult population. The International Liaison Committee on Resuscitation and the American Academy of Pediatrics/American Heart Association Neonatal Resuscitation Program have recognize this difference, however the guidelines almost exclusively rely on data from studies in the adult population or animal studies. Such data may not be wholly applicable to the neonatal population because the most common cause of cardiovascular collapse in the adult is ventricular fibrillation, not asphyxia. Thus, further studies are needed to determine the optimal method for improving hemodynamics and recovery during neonatal resuscitation.

Research question In newborn infants (preterm infants >28 weeks' gestation and term infants) requiring CPR, does CC during sustained inflation compared to 3:1 compression to ventilation ratio improves return of spontaneous circulation (ROSC)?

Primary objective: To prove that CC during sustained inflation will improve recovery from CPR in preterm and term newborns with faster ROSC than that by 3:1 CPR technique.

Secondary objectives: To examine i) if CC during sustained inflation will improve short- and long-term outcomes in preterm and term newborns, and ii) the value of feedback devices (e.g. ECO2, ECG and/or SpO2) in determining ROSC.