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

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

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Intensive Care
• Intervention / Treatment: Procedure: Two-handed facemask hold; Procedure: Control: One-handed facemask hold

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Leinster
    • Dublin, Leinster, Ireland, D02 YH21
      • The National Maternity Hospital Dublin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: Two-handed facemask hold; 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.	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.
Placebo Comparator: Control: One-handed facemask hold; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mask leak	Mask leak percentage, as measured by the Monivent Respiratory Function Monitor (RFM). Collected over a minimum of 5 breaths. Maximum of 2 episodes of facemask ventilation will be collected, with values averaged.	Over a maximum of 20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lowest oxygen saturation	Lowest oxygen saturation detected on the bedside clinical monitoring (Philips Intellivue MX800) during the period of facemask ventilation, recorded by a member of the research team.	Over a maximum of 20 minutes
Highest supplemental FiO2 used during facemask ventilation	Highest percentage FiO2 used during the period of facemask ventilation, as indicated by the set dial on the Neopuff.	Over a maximum of 20 minutes
Positive inspiratory pressure during facemask ventilation	Positive inspiratory pressure used during the period of facemask ventilation, as measured by the Monivent Neo100 respiratory function monitor.	Over a maximum of 20 minutes
Percentage of obstructed breaths during facemask ventilation	Percentage of obstructed breaths during the period of facemask ventilation, as measured by the Monivent Neo100 respiratory function monitor.	Over a maximum of 20 minutes
Tidal volume during facemask ventilation	Measured tidal volume during the period of facemask ventilation, as measured by the Monivent Neo100 respiratory function monitor.	Over a maximum of 20 minutes
Number of times facemask position is adjusted during facemask ventilation	Number of times clinical team needs to adjust mask position during the period of facemask ventilation.	Over a maximum of 20 minutes
Duration of facemask ventilation	Time duration of facemask ventilation	Over a maximum of 20 minutes
Crossover to other handhold	If allocated two-handed hold: Number of times clinical team elect to switch to one-handed hold. If allocated one-handed hold: Number of times clinical team elect to switch to two-handed hold.	Over a maximum of 20 minutes
User opinion of mask hold	Survey of operator opinions about mask hold used, and their usual preference.	Over a maximum of 20 minutes
Lowest heart rate	Lowest heart rate detected on the bedside clinical monitoring (Philips Intellivue MX800) during the period of facemask ventilation, recorded by a member of the research team.	Over a maximum of 20 minutes

Collaborators and Investigators

• Sponsor: University College Dublin

Publications and helpful links

General Publications

• Newborn Life Support. J. Fawke et al. Resuscitation Council UK. May 2021.
• Shah D, Tracy MB, Hinder MK, Badawi N. One-person versus two-person mask ventilation in preterm infants at birth: a pilot randomised controlled trial. BMJ Paediatr Open. 2023 Feb;7(1):e001768. doi: 10.1136/bmjpo-2022-001768.
• Tracy MB, Klimek J, Coughtrey H, Shingde V, Ponnampalam G, Hinder M, Maheshwari R, Tracy SK. Mask leak in one-person mask ventilation compared to two-person in newborn infant manikin study. Arch Dis Child Fetal Neonatal Ed. 2011 May;96(3):F195-200. doi: 10.1136/adc.2009.169847. Epub 2010 Nov 11.
• Murray A, Beechinor T, Livingstone V, Dempsey E. Two hands are better than one: Positive pressure ventilation in a preterm neonatal manikin model. Acta Paediatr. 2024 May;113(5):989-991. doi: 10.1111/apa.17156. Epub 2024 Feb 22. No abstract available.
• Wood FE, Morley CJ. Face mask ventilation--the dos and don'ts. Semin Fetal Neonatal Med. 2013 Dec;18(6):344-51. doi: 10.1016/j.siny.2013.08.009. Epub 2013 Sep 14.
• Weiner GM, Zaichkin J. Updates for the Neonatal Resuscitation Program and Resuscitation Guidelines. Neoreviews. 2022 Apr 1;23(4):e238-e249. doi: 10.1542/neo.23-4-e238.
• O'Currain E, O'Shea JE, McGrory L, Owen LS, Kamlin O, Dawson JA, Davis PG, Thio M. Smaller facemasks for positive pressure ventilation in preterm infants: A randomised trial. Resuscitation. 2019 Jan;134:91-98. doi: 10.1016/j.resuscitation.2018.12.005. Epub 2018 Dec 17.

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Actual): April 21, 2026
• Study Completion (Actual): April 21, 2026

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Neonatology; Facemask ventilation; Face mask ventilation; Mask hold; One-handed mask hold; One-handed hold; Mask leak
• Other Study ID Numbers: EC36.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be pseudononymised and will be presented/shared only as collated values, as opposed to individual results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No