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.
Trial registration: ClinicalTrials.gov NCT00443118.
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