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

NCT06740344 | Recruiting

• 1 other identifier: EC36.2024
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neonatal Intensive Care

Keywords

Neonatology; Facemask ventilation; Face mask ventilation; Mask hold; One-handed mask hold; One-handed hold; Mask leak

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Lowest oxygen saturation

  Over a maximum of 20 minutes

• Highest supplemental FiO2 used during facemask ventilation

  Over a maximum of 20 minutes

• Positive inspiratory pressure during facemask ventilation

  Over a maximum of 20 minutes

• Percentage of obstructed breaths during facemask ventilation

  Over a maximum of 20 minutes

• Tidal volume during facemask ventilation

  Over a maximum of 20 minutes

Study Arms (2)

Intervention: Two-handed facemask hold

EXPERIMENTAL

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

Control: One-handed facemask hold

PLACEBO COMPARATOR

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

Interventions

Two-handed facemask hold PROCEDURE

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

Intervention: Two-handed facemask hold

Control: One-handed facemask hold PROCEDURE

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

Control: One-handed facemask hold

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Neonates with a congenital malformation that would impact mask seal will not be included.

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (1)

The National Maternity Hospital Dublin

Dublin, Leinster, D02 YH21, Ireland

RECRUITING

Related Publications (7)

• Newborn Life Support. J. Fawke et al. Resuscitation Council UK. May 2021.

  BACKGROUND

• 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.

  PMID: 36746525 BACKGROUND

• 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.

  PMID: 21071683 BACKGROUND

• 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.

  PMID: 38389164 BACKGROUND

• 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.

  PMID: 24041823 BACKGROUND

• 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.

  PMID: 35362042 BACKGROUND

• 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.

  PMID: 30572069 BACKGROUND

Central Study Contacts

Laura Ryan

CONTACT

00353851551609; laura.ryan5@gmail.com

Eoin O'Currain

CONTACT

003531 6373498; eoinocurrain@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an unblinded study as it is not possible to blind the provider to the type of mask hold. However, the operators will be blinded to the respiratory function monitor measurements feedback. This will be achieved by obscuring the colour sensor with brown, opaque tape and covering the Monivent screen. The outcome assessor will be blinded to the group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel group randomised controlled trial

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 18, 2024
• Study Start: January 27, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)