NCT06740344

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: University College Dublin · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

This study will compare the measured leak in mask ventilation delivered by a healthcare professional in the neonatal team, using a one-handed versus a two-handed hold with a standardised mask size and shape. This is to assess the two-handed technique as a potential first-line approach in neonatal bag-mask ventilation. The handholds will be assessed by a randomised controlled trial, with the two-handed hold as the intervention and the one-handed hold as the control. The population that will be studied is neonates in the neonatal intensive care unit (NICU), at any gestation, who the clinical team have decided to intubate. A member of the research team, who will provide an out-of-hours on call service, will attend the event. The relevant outcomes will be measured by the Monivent Neo100, which will be set up by the research team. Standardised masks, as used per local protocol, will be used, with the sensor module placed between that and the T-piece with an adaptor. The outcomes will assess the effectiveness of both the intervention and control, including ventilation parameters recorded by the Monivent Neo100 and the clinical stability of the patient. The primary outcome of this study is the percentage mask leak. A research team member will record data for primary and secondary outcome. The event will be filmed for post-hoc video analysis. The outcome assessor will be blinded to the group allocation. This research project will take place over 24 months, with an interim analysis to ensure recruitment is projected to achieve sample size.

Conditions

• Neonatal Intensive Care

Interventions

Type	Name	Description
PROCEDURE	Two-handed facemask hold	Two-handed mask hold technique while giving facemask ventilation, with another operator designated to deliver PIP via the T-piece.
PROCEDURE	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.

Timeline

• Start date: 2025-01-27
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-12-18
• Last updated: 2025-04-11

Locations

1 site across 1 country: Ireland