Pilot study: Randomised controlled trial of interface use during stabilisation of preterm infants in the delivery room

During resuscitation of preterm infants at birth it is essential to deliver
adequate tidal volume and a consistent level of positive end-expiratory
pressure (PEEP). The most frequent used devices are the self-inflating bag or a
mechanical T-piece device, both with a mask as interface.1 Studies2, 3 have
shown that inadequate sealing between face and mask often leads to
inappropriate and inconsistent peak inspiratory pressures (PIP) and PEEP, which
may be harmful and leads to need for intubation.

There is limited data that the use of prongs or a nasopharyngeal tube to
deliver efficient PIP and PEEP during resuscitation alleviates dependence on
sufficient sealing by a facemask, providing that both the mouth and the other
nostril are closed.

The aim of this study is to test the hypothesis that using nasal tube as
interface during resuscitation/stabilisation of preterm infants at birth is
more effective compared to mask.

This is a single-center non-blinded randomized controlled trial.

Resuscitation will be with the allocated device either the nasal tube or the
mask. In both groups the Neopuff, a mechanical resuscitator with a T-piece,
will be used. Other than allocation of the type of interface, the technique of
resuscitation will not be affected in any way by this study. All other
resuscitative measures (e.g. intubation, external cardiac massage,
administration of oxygen and other drugs) will be at the discretion of the
staff involved, following international guidelines.
Criteria for intubation in the delivery room and in the NICU are protocolized
and will be followed as strictly as possible.

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