Published in

American Academy of Pediatrics, Pediatrics, 2(132), p. e381-e388, 2013

DOI: 10.1542/peds.2013-0361

Links

Tools

Export citation

Search in Google Scholar

Mask Versus Nasal Tube for Stabilization of Preterm Infants at Birth: A Randomized Controlled Trial

This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

Full text: Download

Red circle
Preprint: archiving forbidden
Orange circle
Postprint: archiving restricted
Red circle
Published version: archiving forbidden
Data provided by SHERPA/RoMEO

Abstract

OBJECTIVE: Positive-pressure ventilation (PPV) using a manual ventilation device and a face mask is recommended for compromised newborn infants in the delivery room (DR). Mask ventilation is associated with airway obstruction and leak. A nasal tube is an alternative interface, but its safety and efficacy have not been tested in extremely preterm infants. METHODS: An unblinded randomized controlled trial was conducted in Australia, and the Netherlands. Infants were stratified by gestational age (24–25/26–29 weeks) and center. Immediately before birth infants were randomly assigned to receive PPV and/or continuous positive airway pressure with either a nasal tube or a size 00 soft, round silicone mask. Resuscitation protocols were standardized; respiratory support was provided using a T-piece device commencing in room air. Criteria for intubation included need for cardiac compressions, apnea, continuous positive airway pressure >7 cm H2O, and fraction of inspired oxygen >0.4. Primary outcome was endotracheal intubation in the first 24 hours from birth. RESULTS: Three hundred sixty-three infants were randomly assigned; the study terminated early on the grounds of futility. Baseline variables were similar between groups. Intubation rates in the first 24 hours were 54% and 55% in the nasal tube and face mask groups, respectively (odds ratio: 0.97; 95% confidence interval: 0.63–1.50). There were no important differences in any of the secondary outcomes within the whole cohort or between the 2 gestational age subgroups. CONCLUSIONS: In infants at <30 weeks’ gestation receiving PPV in the DR, there were no differences in short-term outcomes using the nasal tube compared with the face mask.