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Search / Trial NCT06740344

Neonatal Mask Seal; a Two-handed Versus One-handed Approach: The NeoSeal Study

Launched by UNIVERSITY COLLEGE DUBLIN · Dec 13, 2024

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Neonatology Facemask Ventilation Face Mask Ventilation Mask Hold One Handed Mask Hold One Handed Hold Mask Leak

ClinConnect Summary

The NeoSeal Study is looking at how to help babies who are having trouble breathing by using a facemask. When doctors use a facemask to give breaths and oxygen to these babies, they can hold the mask with either one hand or two hands. Both methods are recommended, but it's not clear which one works better to prevent air from leaking around the mask. This study will compare the two methods to see which one helps babies get better breathing support.

If your baby is in the neonatal unit and needs help with breathing, they may be eligible to participate in this study. This includes all term and preterm babies who the medical team has decided need to be intubated (a procedure to help them breathe) and require mask ventilation beforehand. Participants will be randomly assigned to either the one-handed or two-handed mask hold, and the researchers will measure how much air leaks around the mask during the process. It's important to note that babies with certain birth defects affecting their ability to wear the mask won't be included in the study. This research aims to improve the care provided to newborns who need breathing support.

Gender

ALL

Eligibility criteria

  • 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.

About University College Dublin

University College Dublin (UCD) is a leading research institution in Ireland, renowned for its commitment to advancing health sciences through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, UCD integrates cutting-edge scientific inquiry with practical applications to enhance patient care and public health outcomes. The university's clinical trial initiatives are bolstered by state-of-the-art facilities, a diverse pool of research expertise, and robust partnerships with healthcare providers and industry stakeholders. UCD is dedicated to fostering a culture of ethical research practices and ensuring the highest standards of scientific rigor in all clinical trials it sponsors.

Locations

Dublin, Leinster, Ireland

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported