Comparing one-handed and two-handed mask holds for neonatal ventilation
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
This study tests whether using one hand or two hands to hold a mask helps babies in the NICU breathe better by reducing air leaks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Sex | All |
| Sponsor | University College Dublin Academic / other |
| Locations | 1 site (Dublin, Leinster) |
| Trial ID | NCT06740344 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of one-handed versus two-handed facemask holds in providing ventilation to neonates in the neonatal intensive care unit (NICU). Babies requiring intubation will be randomly assigned to either technique, and the amount of air leakage around the mask will be measured using a specialized device. The goal is to determine which method provides better respiratory support by minimizing air leaks. The study will be conducted over 24 months, with outcomes assessed by blinded evaluators.
Who should consider this trial
Good fit: Ideal candidates include all term and preterm neonates in the NICU who require mask ventilation prior to intubation.
Not a fit: Patients with congenital malformations affecting mask seal will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve ventilation techniques for neonates, leading to better respiratory support and outcomes.
How similar studies have performed: While there is limited evidence directly comparing these two techniques, the study aims to fill a gap in current clinical guidelines, suggesting a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dublin, Leinster
- The National Maternity Hospital Dublin — Dublin, Leinster, Ireland (Recruiting)
Study contacts
- Study coordinator: Laura Ryan
- Email: laura.ryan5@gmail.com
- Phone: 00353851551609
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.