Abstract

Objective To evaluate the effectiveness and safety of a T-piece resuscitator compared with a self-inflating bag for providing mask ventilation to newborns at birth. Study design Newborns at >= 26 weeks gestational age receiving positive-pressure ventilation at birth were included in this multicenter cluster-randomized 2-period crossover trial. Positive-pressure ventilation was provided with either a self-inflating bag (self-inflating bag group) with or without a positive end-expiratory pressure valve or a T-piece with a positive end-expiratory pressure valve (T-piece group). Delivery room management followed American Academy of Pediatrics and International Liaison Committee on Resuscitation guidelines. The primary outcome was the proportion of newborns with heart rate (HR) >= 100 bpm at 2 minutes after birth. Results A total of 1027 newborns were included. There was no statistically significant difference in the incidence of HR >= 100 bpm at 2 minutes after birth between the T-piece and self-inflating bag groups: 94% (479 of 511) and 90% (466 of 516), respectively (OR, 0.65; 95% CI, 0.41-1.05; P = .08). A total of 86 newborns (17%) in the T-piece group and 134 newborns (26%) in the self-inflating bag group were intubated in the delivery room (OR, 0.58; 95% CI, 0.4-0.8; P = .002). The mean +/- SD maximum positive inspiratory pressure was 26 +/- 2 cm H2O in the T-piece group vs 28 +/- 5 cm H2O in the self-inflating bag group (P < .001). Air leaks, use of drugs/chest compressions, mortality, and days on mechanical ventilation did not differ significantly between groups. Conclusion There was no difference between the T-piece resuscitator and a self-inflating bag in achieving an HR of >= 100 bpm at 2 minutes in newborns >= 26 weeks gestational age resuscitated at birth. However, use of the T-piece decreased the intubation rate and the maximum pressures applied.