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

University College Dublin

Status: Enrolling

Conditions: Neonatal Intensive Care

Treatments: Procedure: Control: One-handed facemask hold; Procedure: Two-handed facemask hold

Study type: Interventional

Funder types: Other

Identifiers

NCT06740344

EC36.2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups, including a placebo group

Intervention: Two-handed facemask hold

Experimental group

Description:

Two-handed mask hold technique while giving facemask ventilation, with another operator designated to deliver positive inspiratory pressure (PIP) via the T-piece. The operators may be any member of the neonatal team, who have undergone Neonatal Resusctiation Programme (NRP) certification. Standardised mask size and shape for gestation and weight, as per local policy, will be used.

Treatment:

Procedure: Two-handed facemask hold

Control: One-handed facemask hold

Placebo Comparator group

Description:

One-handed mask hold technique while giving facemask ventilation, with the same operator holding the mask and delivering positive pressure ventilation (PPV) via the T-piece.

Treatment:

Procedure: Control: One-handed facemask hold