title: 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.
authors.affiliation: Newborn Services, The Royal Women’s Hospital, Melbourne, Australia. omar.kamlin@thewomens.org.au
authors.forename: C Omar F
authors.initials: CO
authors.lastname: Kamlin
authors.forename: Kim
authors.initials: K
authors.lastname: Schilleman
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Dawson
authors.forename: Enrico
authors.initials: E
authors.lastname: Lopriore
authors.forename: Susan M
authors.initials: SM
authors.lastname: Donath
authors.forename: Georg M
authors.initials: GM
authors.lastname: Schmölzer
authors.forename: Frans J
authors.initials: FJ
authors.lastname: Walther
authors.forename: Peter G
authors.initials: PG
authors.lastname: Davis
authors.forename: Arjan B
authors.initials: AB
authors.lastname: Te Pas
mesh_terms: D000402:Airway Obstruction / Q000209:etiology; D015331:Cohort Studies; D045422:Continuous Positive Airway Pressure / Q000295:instrumentation*; D057239:Early Termination of Clinical Trials; D019544:Equipment Failure Analysis; D005865:Gestational Age; D006801:Humans; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D019102:Infant, Very Low Birth Weight; D007442:Intubation, Intratracheal; D008397:Masks; D009426:Netherlands; D012127:Respiratory Distress Syndrome, Newborn / Q000628:therapy*; D012151:Resuscitation; D014739:Victoria
keywords: infant; nasal ventilation; neonatal resuscitation; newborn; positive-pressure ventilation; prematurity