Mask Versus Nasal Tube for Stabilization of Preterm Infants at Birth: A Randomized Controlled Trial
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.
- BPD —
- bronchopulmonary dysplasia
- CPAP —
- continuous positive airway pressure
- DR —
- delivery room
- ETT —
- endotracheal tube
- HR —
- heart rate
- ILCOR —
- International Liaison Committee on Resuscitation
- IQR —
- interquartile range
- LUMC —
- Leiden University Medical Center
- NP —
- nasal prong
- NRP —
- Neonatal Resuscitation Program
- PEEP —
- positive end-expiratory pressure
- SI —
- sustained inflation
- Spo2 —
- pulse oxygen saturation
- RWH —
- Royal Women’s Hospital, Melbourne
- Accepted April 29, 2013.
- Copyright © 2013 by the American Academy of Pediatrics