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

NCT07524517 | Not Yet Recruiting

• 1 other identifier: EC05.2026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neonatal Intensive Care

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

Outcome Measures

Primary Outcomes (1)

• 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 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: Anatomical facemask

EXPERIMENTAL

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

Control: Round facemask

ACTIVE COMPARATOR

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

Interventions

Control: Round facemask DEVICE

Round facemask, with a two-handed hold, to deliver positive pressure ventilation via a mask.

Control: Round facemask

Intervention: Anatomical facemask DEVICE

Anatomical facemask, with a two-handed hold, to deliver positive pressure ventilation via a mask.

Intervention: Anatomical facemask

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

Location

Related Publications (3)

• 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.

  PMID: 29705115 BACKGROUND

• Shah D,Tracy MB,Hinder MK,Badawi N

  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 J Ryan

CONTACT

+353851551609; 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 facemask used. However, the operators will be blinded to the respiratory function monitor measurements feedback. This will be achieved by obscuring the colour sensor with an opaque covering 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: April 3, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)