Smaller facemasks for positive pressure ventilation in preterm infants: A randomised trial

Facial measurements of preterm infants indicate that standard diameter facemasks used during positive pressure ventilation are too large, which may lead to mask leak and compromise resuscitation. We aimed to determine whether the use of a facemask that better complies with the dimensions of preterm faces, compared with a standard facemask, reduces facemask leak.

Parallel group, randomised controlled trial. Preterm infants ≤32 weeks' gestation receiving facemask ventilation prior to intubation in the neonatal intensive care unit, and those 28-32⁺⁶ weeks' receiving facemask ventilation in the delivery room were eligible. Infants were randomised to receive ventilation via a standard (50mm) (control), or a smaller (35mm or 42mm) diameter facemask (intervention), stratified by gestation (≤26 weeks'; 35mm, 27-32⁺⁶; 42mm). The primary outcome was leak between the mask and the infants face.

Of 298 eligible infants, 139 were randomised and 131 were included in the final analysis; 66 in the intervention group and 65 in the control group. The median (IQR) leak was 42% (13-69%) in the intervention group compared with 39% (22-66%) in the control group P=0.43. The median (IQR) lowest oxygen saturation was similar in both groups [intervention 70% (34-93%) vs. control 71% (40-93%) P=0.75]. One infant crossed over from the intervention to the control group due to poor response to ventilation with the intervention facemask.

Smaller facemasks did not reduce mask leak in preterm facemask ventilation. All facemasks had high leak, particularly in infants ≤26 weeks' gestation.

This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12614000709640, www.anzctr.org.au.