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A Randomised Controlled Trial of Face Mask or Nasal Tube to Provide Respiratory Support to Preterm Infants in the Delivery Room

Presented at the Neonatal Society 2013 Spring Meeting.

Kamlin COF1,2, Schilleman K3, Dawson JA1,2, Loprioire E3, Donath SM2, Schmoelzer GM1, Walther FJ3, Davis PG1,2, tePas AB3

1 Royal Women’s Hospital, Melbourne, Australia
2 University of Melbourne, Australia
3 Leiden University Medical Center, Leiden, Netherlands

Background: Positive pressure ventilation (PPV) using a manual ventilation device and a face mask is recommended for compromised newly born infants in the DR. Mask ventilation is associated with airway obstruction and leak which may contribute to failure of resuscitation (1). A nasal tube is an alternative interface. Its safety and efficacy have not been evaluated in extremely preterm infants.

Methods: An RCT conducted in two centres. Variable block sizes were used and infants were stratified by GA, (24-25 & 26-29 weeks), and centre. Infants were randomized immediately prior to birth to receive PPV and/or continuous positive airway pressure (CPAP) with either a nasal tube or Laerdal size 00 round silicone mask. Resuscitation protocols were standardised; respiratory support was delivered using a T Piece ventilator commencing in room air. Criteria for intubation included need for cardiac compressions, apnoea, CPAP > 7cmH2O and FiO2 > 0.4. The primary outcome was endotracheal intubation in the first 24 hours from birth.

Results: Three hundred and sixty three infants (63 & 300 in lower and higher gestational subgroups respectively were randomised. Baseline variables were similar and there were no significant differences in any of the outcomes. The primary outcome of endotracheal intubation in the first 24 hours from birth was 54% and 55% in the nasal tube and face mask groups respectively [OR (95%CI) 0.99 (0.65-1.54)]. The composite outcome of either death or BPD at 36 weeks corrected gestational age was 36% and 37% in the nasal tube and face mask groups respectively [OR (95%CI) 0.97 (0.61-1.51).

Conclusion: In infants <30 weeks gestation receiving PPV in the DR, using a nasal tube does not reduce the risk of early intubation compared to soft silicone round face mask. Either interface can be used to stabilise preterm infants.

Corresponding author: omar.kamlin@thewomens.org.au

1. Schilleman, K. et al ADC Fetal Neonatal Ed. 2010

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