NeoSHARK: Anatomical Versus Round Facemasks for Breathing Support in Preterm and Term Newborn Infants

Condition(s) studied

Investigational drug(s) / intervention(s)

Intervention: Anatomical facemask: Anatomical facemask, with a two-handed hold, to deliver positive pressure ventilation via a mask.

Control: Round facemask: Round facemask, with a two-handed hold, to deliver positive pressure ventilation via a mask.

Study summary

When babies can't breathe effectively, we can use a facemask to give them breaths and oxygen. There are various types of facemasks that can be used, including round and anatomical (triangular) masks, depending on the preference of the hospital, but it is unclear if one is better for the baby. Both types of facemasks are recommended in international guidelines, without any advice whether one is better than the other. Previous studies published by our research group demonstrated that a variety of different masks are used around the hospitals in Ireland. If a lot of air is leaking around the mask, it means that the baby is not getting the full breathing support that we are trying to give. We currently do not have enough evidence to say which type of mask is better to reduce the risk of this potential leaking of air.

Recent studies have suggested that holding a mask with two hands (instead of one) is better in round facemasks. The combination of an anatomical mask and a two-handed hold has not yet been studied in babies.

In this study, we will compare two different facemasks (round and anatomical) when holding the mask on a baby's face with two hands to help them breathe. We will randomly allocate each baby to either a round mask or an anatomical (triangular) mask and we will measure how much air leaks out around the mask during each breath. We will do this in babies who are in the neonatal unit.

Eligibility

Primary outcome measure(s)

• Mask leak — Over a maximum of 20 minutes
  Mask leak percentage, as measured by the Monivent Respiratory Function Monitor (RFM), with a minimum of 5 breaths collected. Maximum of 2 episodes of facemask ventilation will be collected, with values averaged.

Trial sites (1)

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