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

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.

Prematurely born infants' response to resuscitation via an endotracheal tube or a face mask

“…We would suggest that the higher ETCO 2 levels in the intubated infants reflect their higher expired tidal volumes. A recent randomised trial [13] of non-invasive respiratory support via either a face mask or a nasal tube in the delivery room was terminated early on the grounds of futility. Those results [13], therefore, do not suggest if we had used a different method of delivering non-invasive respiratory support compared to intubation it would have influenced our results.…”

Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure

“…The prospect of having to walk into a delivery room to discuss research participation when a woman is giving birth to an infant who is potentially severely ill is causing great concern to the trial team. 1 Similar dilemmas are faced by child health researchers across the globe. Randomized controlled trials (RCTs) (Box 1) and other well-conducted clinical studies are necessary to generate evidence to inform decision making about interventions, and, ultimately, to improve child health.…”

Resuscitation and support of transition of babies at birth

“…Mithilfe von Atemfunktionsmonitoren lassen sich Beatmungsdruck und Tidalvolumen messen und anzeigen [189,[192][193][194][195], mit einer CO 2 -Messung kann man ausgeatmetes CO 2 bestimmen [197,198] [199,200].…”