An interventional study of Intervention: Anatomical facemask and Control: Round facemask in Neonatal Intensive Care, sponsored by University College Dublin. Recruiting at 1 site in Ireland. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by University College Dublin · Not applicable, Interventional, and Supportive care
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.
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.
University College Dublin is the lead sponsor of 113 studies on the registry; 32 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
Anatomical facemask, with a two-handed hold, to deliver positive pressure ventilation via a mask.
Round facemask, with a two-handed hold, to deliver positive pressure ventilation via a mask.
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.
Time frame: Over a maximum of 20 minutes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Over a maximum of 20 minutes
Duration of facemask ventilation
Time duration of facemask ventilation
Time frame: 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.
Time frame: Over a maximum of 20 minutes
User opinion of mask hold
Survey of operator opinions about mask hold used, and their usual preference.
Time frame: 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.
Time frame: Over a maximum of 20 minutes
Plan to share: No — Data will be pseudononymised and will be presented/shared only as collated values, as opposed to individual results.
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