NeoSHARK: Anatomical Versus Round Facemasks for Breathing Support in Preterm and Term Newborn Infants (NeoSHARK)

NeoSHARK: Neonatal Study of Two-Handed Anatomical Versus Round facemasK Ventilation in Preterm and Term Infants; a Randomised Controlled Trial

When babies can't breathe effectively, we can use a facemask to give them breaths and oxygen. There are various types of facemasks that can be used, including round and anatomical (triangular) masks, depending on the preference of the hospital, but it is unclear if one is better for the baby. Both types of facemasks are recommended in international guidelines, without any advice whether one is better than the other. Previous studies published by our research group demonstrated that a variety of different masks are used around the hospitals in Ireland. If a lot of air is leaking around the mask, it means that the baby is not getting the full breathing support that we are trying to give. We currently do not have enough evidence to say which type of mask is better to reduce the risk of this potential leaking of air.

Recent studies have suggested that holding a mask with two hands (instead of one) is better in round facemasks. The combination of an anatomical mask and a two-handed hold has not yet been studied in babies.

In this study, we will compare two different facemasks (round and anatomical) when holding the mask on a baby's face with two hands to help them breathe. We will randomly allocate each baby to either a round mask or an anatomical (triangular) mask and we will measure how much air leaks out around the mask during each breath. We will do this in babies who are in the neonatal unit.

Study Overview

• Status: Recruiting
• Conditions: Neonatal Intensive Care
• Intervention / Treatment: Device: Intervention: Anatomical facemask; Device: Control: Round facemask

Detailed Description

Delivering effective facemask ventilation is an essential component of neonatal resuscitation. However, facemask leak of up to 60% in preterm neonates and airway obstruction are common and can be associated with ineffective ventilation of the baby and clinical instability (O'Currain 2019). Multiple characteristics may influence the effectiveness of facemask ventilation, such as operator technique, infant gestation, airway anatomy and tone, as well as facemask size and shape.

The Neonatal Resuscitation Programme (NRP) allows for either type of facemask as per local practice, without recommending a particular shape of that facemask. A recent national airway survey by our group demonstrated that 8/19 centres in Ireland use both anatomical and round facemasks in clinical practice, with 11 different sizes and shapes of facemasks in clinical use in neonatal units in Ireland. While studies to date have not found a difference between anatomical and round masks in neonatal manikins, these studies only included facemask ventilation delivered with a one-handed hold, rather than a two-handed hold. Emerging evidence, including benchtop and clinical data, suggests that a two-handed hold is superior to a one-handed hold in round facemasks. The combination of an anatomical mask and a two-handed hold has not yet been studied in a clinical setting.

This study will compare the measured leak in mask ventilation with a two-handed hold, delivered by a healthcare professional in the neonatal team, using an anatomical versus a round facemask with standardised mask size. The facemasks will be assessed by a randomised controlled trial, with the anatomical mask as the intervention and the round mask 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 mask size, as per local protocol, will be used, with the sensor module placed between the mask 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 outcomes. 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 10 months, with an interim analysis to ensure recruitment is projected to achieve sample size.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eoin O'Currain; Phone Number: 003531 6373498; Email: eoinocurrain@gmail.com
• Study Contact Backup: Name: Laura J Ryan; Phone Number: +353851551609; Email: laura.ryan5@gmail.com

Study Locations

• Ireland
  • Leinster
    • Dublin, Leinster, Ireland, D02 YH21
      • Recruiting
      • The National Maternity Hospital Dublin
      • Contact: Laura J Ryan; Phone Number: 0851551609; Email: laura.ryan5@gmail.com
      • Principal Investigator: Eoin O'Currain
      • Principal Investigator: Anna Curley

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: Anatomical facemask; Anatomical facemask with a two-handed hold while giving facemask ventilation. The operators may be any member of the neonatal team, who have undergone NRP certification. Standardised mask size for gestation and weight, as per local policy, will be used. Educational sessions, including practical training, will be carried out prior to commencing the study to ensure all potential operators are familiar with both types of facemasks.	Device: Intervention: Anatomical facemask; Anatomical facemask, with a two-handed hold, to deliver positive pressure ventilation via a mask.
Active Comparator: Control: Round facemask; Round facemask with a two-handed hold while giving facemask ventilation. The operators may be any member of the neonatal team, who have undergone NRP certification. Standardised mask size for gestation and weight, as per local policy, will be used.	Device: Control: Round facemask; Round facemask, with a two-handed hold, to deliver positive pressure ventilation via a mask.

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), with a minimum of 5 breaths collected. 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

• 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.
• 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.
• Lorenz L, Ruegger CM, O'Currain E, Dawson JA, Thio M, Owen LS, Donath SM, Davis PG, Kamlin COF. Suction Mask vs Conventional Mask Ventilation in Term and Near-Term Infants in the Delivery Room: A Randomized Controlled Trial. J Pediatr. 2018 Jul;198:181-186.e2. doi: 10.1016/j.jpeds.2018.03.013. Epub 2018 Apr 25.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

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

More Information

Terms related to this study

• Keywords: Neonatology; Facemask ventilation; Face mask ventilation; Anatomical face mask; Round face mask; Two-handed mask hold; Two-handed facemask ventilation; Neonatal mask shape comparison
• Other Study ID Numbers: EC05.2026

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