Neonatal Intensive CareNeoSealNCT06740344
Neonatal Mask Seal; a Two-handed Versus One-handed Approach: The NeoSeal Study
A study testing Two-handed facemask hold 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. 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neonatal Intensive Care
- What is being tested?
- Two-handed facemask hold
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteIreland
- Study dates
- 27 Jan 2025to 21 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
Ireland1 site
The National Maternity Hospital Dublin
Dublin, Leinster, D02 YH21
About this study
Official title: Neonatal Mask Seal; a Randomised Controlled Trial of Two-handed Versus One-handed Hold for Delivering Positive-pressure Ventilation With a Facemask in Preterm and Term Infants: The NeoSeal Study
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.
Read the detailed description
This study will compare the measured leak in mask ventilation delivered by a healthcare professional in the neonatal team, using a one-handed versus a two-handed hold with a standardised mask size and shape. This is to assess the two-handed technique as a potential first-line approach in neonatal bag-mask ventilation.
The handholds will be assessed by a randomised controlled trial, with the two-handed hold as the intervention and the one-handed hold 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 masks, as used per local protocol, will be used, with the sensor module placed between that 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 outcome. 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 24 months, with an interim analysis to ensure recruitment is projected to achieve sample size.
- Conditions
- Neonatal Intensive Care
- Being tested
- Two-handed facemask hold, Control: One-handed facemask hold
- Keywords
- Neonatology, Facemask ventilation, Face mask ventilation, Mask hold, One-handed mask hold, One-handed hold, Mask leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-handed facemask holdProcedure or surgery
Two-handed mask hold technique while giving facemask ventilation, with another operator designated to deliver PIP via the T-piece.
Control: One-handed facemask holdProcedure or surgery
One-handed mask hold technique while giving facemask ventilation, with the same operator holding the mask and delivering PPV via the T-piece.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Control: One-handed facemask hold |
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).
Collected over a minimum of 5 breaths. 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 posted18 Dec 2024
- Study start27 Jan 2025
- Primary completion21 Apr 2026
- Study completion21 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740344
- Sponsor's protocol ID
- EC36.2024
- Acronym
- NeoSeal
- Status last verified
- Apr 2026
- First submitted
- 21 Nov 2024
- 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
Newborn Life Support. J. Fawke et al. Resuscitation Council UK. May 2021.
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.
PubMed 36746525Tracy 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.
PubMed 21071683Murray 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.
PubMed 38389164Wood 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.
PubMed 24041823Weiner 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.
PubMed 35362042O'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
- Neonatal Mask Seal; a Randomised Controlled Trial of Two-handed Versus One-handed Hold for Delivering Positive-pressure Ventilation With a Facemask in Preterm and Term Infants: The NeoSeal Study
- ClinicalTrials.gov ID
- NCT06740344
- Acronym / sponsor ID
- NeoSeal / EC36.2024
- Conditions
- Neonatal Intensive Care
- Keywords
- Neonatology, Facemask ventilation, Face mask ventilation, Mask hold, One-handed mask hold, One-handed hold, Mask leak
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 21 Apr 2026 (actual)
- First posted
- 18 Dec 2024 (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. 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.
Detailed description
This study will compare the measured leak in mask ventilation delivered by a healthcare professional in the neonatal team, using a one-handed versus a two-handed hold with a standardised mask size and shape. This is to assess the two-handed technique as a potential first-line approach in neonatal bag-mask ventilation.
The handholds will be assessed by a randomised controlled trial, with the two-handed hold as the intervention and the one-handed hold 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 masks, as used per local protocol, will be used, with the sensor module placed between that 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 outcome. 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 24 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: Two-handed facemask hold | Experimental | Procedure: Two-handed facemask holdTwo-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. |
| Control: One-handed facemask hold | Placebo comparator | Procedure: Control: One-handed facemask holdOne-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. |
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 |
|---|---|---|
| Two-handed facemask holdTwo-handed mask hold technique while giving facemask ventilation, with another operator designated to deliver PIP via the T-piece. | Procedure or surgery | Intervention: Two-handed facemask hold |
| Control: One-handed facemask holdOne-handed mask hold technique while giving facemask ventilation, with the same operator holding the mask and delivering PPV via the T-piece. | Procedure or surgery | Control: One-handed facemask hold |
Primary outcome
Mask leak
Time frame: Over a maximum of 20 minutes
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.
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Results publicationNewborn Life Support. J. Fawke et al. Resuscitation Council UK. May 2021.
- Results publication: 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.
- Results publication: PubMed 21071683Tracy 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.
- Results publication: PubMed 38389164Murray 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.
- Results publication: PubMed 24041823Wood 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.
- Results publication: PubMed 35362042Weiner 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.
- Results publication: 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.
Related trials for Neonatal Intensive Care
Active, not recruiting
Maternal Sensory Interventions in Newborns
Neonatal Intensive Care Unit, Hospitalized Newborn
Recruiting
Effect of Support for Low-Income Mothers of Preterm Infants
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Recruiting
The Effect of Digitally Enabled District (DED 2.0) Ecosystem on the Completeness and Timeliness of Maternal and Neonatal Services in Primary Health Care
Digital Health, Maternal Health Services
Recruiting
NIRS Monitoring in the NICU and AKI
Acute Kidney Injury (AKI), Postnatal AKI
Not yet recruitingObservational study
Neonatal Thrombocytopenia in the NICU
Thrombocytopenia, Neonatal Thrombocytopenia
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two-handed facemask hold 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: finished, 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT06740344, which also lists 7 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.