Neonatal Intensive CareNeoSHARKNCT07524517
NeoSHARK: Anatomical Versus Round Facemasks for Breathing Support in Preterm and Term Newborn Infants
A study testing Intervention: Anatomical facemask in people with Neonatal Intensive Care, run by University College Dublin at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neonatal Intensive Care
- What is being tested?
- Intervention: Anatomical facemask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIreland
- Study dates
- May 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Neonates with a congenital malformation that would impact mask seal will not be included.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
The National Maternity Hospital Dublin
Dublin, Leinster, D02 YH21
Laura J Ryan, 0851551609, laura.ryan5@gmail.com
Eoin O'Currain
About this study
Official title: 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.
Read the 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.
- Conditions
- Neonatal Intensive Care
- Being tested
- Intervention: Anatomical facemask, Control: Round facemask
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: Anatomical facemaskDevice
Anatomical facemask, with a two-handed hold, to deliver positive pressure ventilation via a mask.
Control: Round facemaskDevice
Round facemask, with a two-handed hold, to deliver positive pressure ventilation via a mask.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Control: Round facemask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Over a maximum of 20 minutes
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Over a maximum of 20 minutes
Duration of facemask ventilation
Time duration of facemask ventilation
Measured: 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.
Measured: Over a maximum of 20 minutes
User opinion of mask hold
Survey of operator opinions about mask hold used, and their usual preference.
Measured: 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.
Measured: Over a maximum of 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neonatal Intensive CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524517
- Sponsor's protocol ID
- EC05.2026
- Acronym
- NeoSHARK
- Status last verified
- May 2026
- First submitted
- 3 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be pseudononymised and will be presented/shared only as collated values, as opposed to individual results.
Publications
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.
PubMed 29705115Shah 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.
PubMed 36746525O'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.
PubMed 30572069
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeoSHARK: Neonatal Study of Two-Handed Anatomical Versus Round facemasK Ventilation in Preterm and Term Infants; a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07524517
- Acronym / sponsor ID
- NeoSHARK / EC05.2026
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention: Anatomical facemask | Experimental | Device: Intervention: Anatomical facemaskAnatomical 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. |
| Control: Round facemask | Active comparator | Device: Control: Round facemaskRound 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Neonates with a congenital malformation that would impact mask seal will not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention: Anatomical facemaskAnatomical facemask, with a two-handed hold, to deliver positive pressure ventilation via a mask. | Device | Intervention: Anatomical facemask |
| Control: Round facemaskRound facemask, with a two-handed hold, to deliver positive pressure ventilation via a mask. | Device | Control: Round facemask |
Primary outcome
Mask leak
Time frame: Over a maximum of 20 minutes
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.
10 secondary outcomes
Lowest oxygen saturation
Time frame: Over a maximum of 20 minutes
Highest supplemental FiO2 used during facemask ventilation
Time frame: Over a maximum of 20 minutes
Positive inspiratory pressure during facemask ventilation
Time frame: Over a maximum of 20 minutes
Percentage of obstructed breaths during facemask ventilation
Time frame: Over a maximum of 20 minutes
Tidal volume during facemask ventilation
Time frame: Over a maximum of 20 minutes
Number of times facemask position is adjusted during facemask ventilation
Time frame: Over a maximum of 20 minutes
Duration of facemask ventilation
Time frame: Over a maximum of 20 minutes
Crossover to other handhold
Time frame: Over a maximum of 20 minutes
User opinion of mask hold
Time frame: Over a maximum of 20 minutes
Lowest heart rate
Time frame: Over a maximum of 20 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 29705115Lorenz 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.
- Background: PubMed 36746525Shah 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.
- Background: PubMed 30572069O'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.
- Individual participant dataSharing planned: No. Data will be pseudononymised and will be presented/shared only as collated values, as opposed to individual results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention: Anatomical facemask in people with Neonatal Intensive Care, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura J Ryan (+353851551609, laura.ryan5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mask leak (time frame: Over a maximum of 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07524517, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.