Neonatal outcomes and resuscitation practices following the addition of heart rate-guidance to basic resuscitation

Aim To evaluate the impact of heart rate-guided basic resuscitation compared to Helping Babies Breathe on neonatal outcomes and resuscitation practices in the Democratic Republic of the Congo. Methods We conducted a pre-post clinical trial comparing heart rate-guided basic resuscitation to Helping Babies Breathe in three facilities, enrolling in-born neonates ≥28 weeks gestation. We collected observational data during a convenience sample of resuscitations and extracted clinical data from the medical record for all participants. We evaluated our primary outcome of effective breathing at three minutes after birth among newborns not breathing well at 30 seconds after birth employing generalized linear models using maximum likelihood estimation. Results Among 1,284 newborns with observational data, there was no difference in the proportion effectively breathing at three minutes (adjusted relative risk 1.08 [95% CI 0.81, 1.45]). Among 145 receiving bag mask ventilation, time to bag mask ventilation decreased 64.3 seconds during heart rate-guided resuscitation (p<0.001). Among 10,906 enrolled in the trial, perinatal mortality was unchanged (adjusted relative risk 1.19 [95% CI 0.96, 1.48]) and death before discharge increased (adjusted relative risk 1.43 [95% CI 1.03, 1.99]). Expert review of stillborn cases demonstrated a stillbirth misclassification rate of 33.3% during Helping Babies Breathe versus 5.9% in heart rate-guided resuscitation. Conclusion During heart rate-guided basic resuscitation, time to bag mask ventilation was reduced by greater than one minute. The increase in death before discharge and unchanged perinatal mortality may be due to resuscitation of newborns with a higher risk of mortality who were previously presumed stillborn. A cluster-randomized trial of heart rate-guided basic resuscitation is needed to evaluate its impact on neonatal mortality in low-resource settings.