Comparison of Devices for Newborn Ventilation in the Delivery Room.

Journal of Pediatrics

PubMedID: 24690329

Szyld E, Aguilar A, Musante GA, Vain N, Prudent L, Fabres J, Carlo WA, Delivery Room Ventilation Devices Trial Group. Comparison of Devices for Newborn Ventilation in the Delivery Room. J Pediatr. 2014;165(2):234-239.e3.
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.