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Neonatal Mask Seal; a Two-handed Versus One-handed Approach: The NeoSeal Study
Sponsor: University College Dublin
Summary
When babies can't breathe effectively, we can use a facemask to give them breaths and oxygen. The mask can be held with one or two hands, depending on the preference of the doctor. Both types of mask holds are recommended in international guidelines, but it is unclear which one is better for the baby. If a lot of air is leaking around the mask, it means that the baby is not getting the full breathing support that the healthcare providers are trying to give. There currently is not enough evidence to say which type of hold is better to reduce this potential leaking of air. In this study, the investigators will compare two different ways of holding a mask on a baby's face to help them breathe. Each baby will be randomly allocated to either a one-handed or a two-handed mask hold, and the investigators will measure how much air leaks out around the mask during each breath. Any baby in the neonatal unit may be included in this study.
Official title: Neonatal Mask Seal; a Randomised Controlled Trial of Two-handed Versus One-handed Hold for Delivering Positive-pressure Ventilation With a Facemask in Preterm and Term Infants: The NeoSeal Study
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2025-01-27
Completion Date
2026-12
Last Updated
2025-04-11
Healthy Volunteers
No
Conditions
Interventions
Two-handed facemask hold
Two-handed mask hold technique while giving facemask ventilation, with another operator designated to deliver PIP via the T-piece.
Control: One-handed facemask hold
One-handed mask hold technique while giving facemask ventilation, with the same operator holding the mask and delivering PPV via the T-piece.
Locations (1)
The National Maternity Hospital Dublin
Dublin, Leinster, Ireland