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

RecruitingNAAges any - anyAllUniversity College Dublin
NCT07524517 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * All term and preterm neonates in the neonatal unit who the clinical team have decided to intubate, with or without pre-medication, and who require mask ventilation prior to intubation attempt. Exclusion Criteria: * Neonates with a congenital malformation that would impact mask seal will not be included.
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What it tests

  • Intervention: Anatomical facemask
  • Control: Round facemask
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Where

1 site
The National Maternity Hospital Dublin
Dublin, Ireland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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