Face Mask Ventilation in Neonatal ResuscitationNCT07161752
Applied Forces During Neonatal Ventilation With Different Face Masks
A study testing Anatomical face mask 1, Anatomical face mask 2 and Round face mask in people with Face Mask Ventilation in Neonatal Resuscitation, run by University Hospital Padova at 1 site in Italy.
Trial summary
This trial compares the applied forces exerted on the face of a modified preterm neonatal manikin with three different face masks. Additionally, percentages of ventilation time with mask leak <25%, and participants' opinion about perceived applied forces, difficulty in achieving an effective ventilation, and… Read more about this study
- Who is it for?
- Ages Up to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Face Mask Ventilation in Neonatal Resuscitation
- What is being tested?
- Anatomical face mask 1, Anatomical face mask 2 and Round face mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2025to 30 Sep 2025
- 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 Up to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Level III neonatal intensive care unit (NICU) consultants, pediatric residents and anesthesiology residents
Who cannot join
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Applied Forces During Neonatal Ventilation With Different Face Masks: a Randomized Crossover Manikin Study.
This trial compares the applied forces exerted on the face of a modified preterm neonatal manikin with three different face masks. Additionally, percentages of ventilation time with mask leak <25%, and participants' opinion about perceived applied forces, difficulty in achieving an effective ventilation, and difficulty in obtaining a good mask seal are investigated.
- Being tested
- Anatomical face mask 1, Anatomical face mask 2, Round face mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomical face mask 1Device
Providing face mask ventilation in a neonatal manikin using a model of anatomical face mask
Anatomical face mask 2Device
Providing face mask ventilation in a neonatal manikin using another model of anatomical face mask
Round face maskDevice
Providing face mask ventilation in a neonatal manikin using a model of round face mask
| Study group | Role | What they receive |
|---|---|---|
| Anatomical face mask 1 | Experimental | Not described Receives: Device: Anatomical face mask 1 |
| Anatomical face mask 2 | Active comparator | Not described Receives: Device: Anatomical face mask 2 |
| Round face mask | Active comparator | Not described Receives: Device: Round face mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Applied forces
The force applied on the manikin head by the operator during the procedure
Measured: 1 minute
Secondary outcomes (2)
Mask leak
Mask leak (measured as percentage of ventilation time with leak less than 25% around the mask)
Measured: 1 minute
Participant opinion
Participants' opinions on the face masks (assessed using a Likert scale, from 1 lowest grade to 5 highest grade)
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start15 Sep 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
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 Face Mask Ventilation in Neonatal ResuscitationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Manikin study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniele Trevisanuto, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161752
- Sponsor's protocol ID
- UNIPDNewborn25
- Status last verified
- Nov 2025
- First submitted
- 2 Sep 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cavallin F, Zamunaro A, Maglio S, Villani PE, Bua B, Gallo D, Menciassi A, Tognarelli S, Trevisanuto D. Applied forces with partially vs. fully inflated face masks during neonatal ventilation: a randomized crossover manikin trial. Pediatr Res. 2026 Feb;99(3):1122-1127. doi: 10.1038/s41390-025-04308-2. Epub 2025 Aug 27.
PubMed 40866603Cavallin F, Sala C, Maglio S, Bua B, Villani PE, Menciassi A, Tognarelli S, Trevisanuto D. Applied forces with direct versus indirect laryngoscopy in neonatal intubation: a randomized crossover mannequin study. Can J Anaesth. 2023 May;70(5):861-868. doi: 10.1007/s12630-023-02402-9. Epub 2023 Feb 14.
PubMed 36788198Gordon JK, Bertram VE, Cavallin F, Parotto M, Cooper RM. Direct versus indirect laryngoscopy using a Macintosh video laryngoscope: a mannequin study comparing applied forces. Can J Anaesth. 2020 May;67(5):515-520. doi: 10.1007/s12630-020-01583-x. Epub 2020 Mar 9.
PubMed 32152886
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applied Forces During Neonatal Ventilation With Different Face Masks: a Randomized Crossover Manikin Study.
- ClinicalTrials.gov ID
- NCT07161752
- Acronym / sponsor ID
- UNIPDNewborn25
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 9 Sep 2025 (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.
This trial compares the applied forces exerted on the face of a modified preterm neonatal manikin with three different face masks. Additionally, percentages of ventilation time with mask leak <25%, and participants' opinion about perceived applied forces, difficulty in achieving an effective ventilation, and difficulty in obtaining a good mask seal are investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Manikin study
| Arm | Type | Receives |
|---|---|---|
| Anatomical face mask 1 | Experimental | Device: Anatomical face mask 1 |
| Anatomical face mask 2 | Active comparator | Device: Anatomical face mask 2 |
| Round face mask | Active comparator | Device: Round face mask |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Level III neonatal intensive care unit (NICU) consultants, pediatric residents and anesthesiology residents
Key exclusion criteria (1 listed)
- Refusal to participate
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 |
|---|---|---|
| Anatomical face mask 1Providing face mask ventilation in a neonatal manikin using a model of anatomical face mask | Device | Anatomical face mask 1 |
| Anatomical face mask 2Providing face mask ventilation in a neonatal manikin using another model of anatomical face mask | Device | Anatomical face mask 2 |
| Round face maskProviding face mask ventilation in a neonatal manikin using a model of round face mask | Device | Round face mask |
Primary outcome
Applied forces
Time frame: 1 minute
The force applied on the manikin head by the operator during the procedure
2 secondary outcomes
Mask leak
Time frame: 1 minute
Participant opinion
Time frame: 2 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 20 Nov 2025.
- Background: PubMed 40866603Cavallin F, Zamunaro A, Maglio S, Villani PE, Bua B, Gallo D, Menciassi A, Tognarelli S, Trevisanuto D. Applied forces with partially vs. fully inflated face masks during neonatal ventilation: a randomized crossover manikin trial. Pediatr Res. 2026 Feb;99(3):1122-1127. doi: 10.1038/s41390-025-04308-2. Epub 2025 Aug 27.
- Background: PubMed 36788198Cavallin F, Sala C, Maglio S, Bua B, Villani PE, Menciassi A, Tognarelli S, Trevisanuto D. Applied forces with direct versus indirect laryngoscopy in neonatal intubation: a randomized crossover mannequin study. Can J Anaesth. 2023 May;70(5):861-868. doi: 10.1007/s12630-023-02402-9. Epub 2023 Feb 14.
- Background: PubMed 32152886Gordon JK, Bertram VE, Cavallin F, Parotto M, Cooper RM. Direct versus indirect laryngoscopy using a Macintosh video laryngoscope: a mannequin study comparing applied forces. Can J Anaesth. 2020 May;67(5):515-520. doi: 10.1007/s12630-020-01583-x. Epub 2020 Mar 9.
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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. 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 Anatomical face mask 1, Anatomical face mask 2 and Round face mask in people with Face Mask Ventilation in Neonatal Resuscitation, run by University Hospital Padova at 1 site in Italy.
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 20 Nov 2025. 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 Italy. 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?
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?
Applied forces (time frame: 1 minute). 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 NCT07161752, 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 20 Nov 2025.