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Infant, Newborn, DiseasesIntubAIDNCT06139809

Noninvasive Positive Pressure Ventilation During Neonatal Nasal Intubation

A study testing Intubation in people with Infant, Newborn, Diseases and Intubation Complication, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to perform a quality control assessment of our local intubation protocol in any newborn infant requiring endotracheal intubation in the delivery room or neonatal intensive care unit at the Department of Neonatology of the University Hospital Zurich. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Intubation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSwitzerland
Study dates
31 Mar 2024to 5 Oct 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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Any neonate at the Department of Neonatology of the University Hospital Zurich undergoing endotracheal intubation in the delivery room or neonatal intensive care unit.

Who cannot join

  • Requirement for immediate endotracheal intubation as determined by the treating clinician, without time for potential application of NIPPV, e.g. active cardiopulmonary resuscitation.
  • Contraindication to NIPPV use (e.g. congenital diaphragmatic hernia, abdominal wall defects).
  • Oral intubation planned.
  • Denial of parental consent and/or inability of the parents to understand the study procedures due to cognitive or linguistic reasons.
  • Withdrawal at the discretion of the intubating clinician if he / she feels the study is interfering with a safe and optimal treatment of the patient.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital Zurich

    Zurich

Other trials in Switzerland

About this study

Official title: The IntubAID Study - Noninvasive Positive Pressure Ventilation During Neonatal Nasal Intubation

The goal of this study is to perform a quality control assessment of our local intubation protocol in any newborn infant requiring endotracheal intubation in the delivery room or neonatal intensive care unit at the Department of Neonatology of the University Hospital Zurich. The primary aims are:

  • Successful nasal intubation at the first attempt without physiological instability.
  • Comparison of infants with successful intubation at the first attempt without physiological instability to the infants in the SHINE-Trial in Australia.

Participants will be intubated according to our standard intubation procedure using non-invasive ventilation (NIV) delivered through a nasopharyngeal tube.

Being tested
Intubation
Keywords
Intubation, Non-invasive ventilation, Non-invasive positive pressure ventilation, Continuous positive airway pressure, Mechanical ventilation, Physiological stability
Medical subject headings
Infant, Newborn, Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IntubationProcedure or surgery

    Intubation will take place according to our local standard protocol for nasal intubation using NIPPV delivered through a nasopharyngeal tube. The intubation will be video-recorded to provide a clear view of the procedure and the pulse oximeter displaying the SpO2 and HR.

Study groups in NCT06139809
Study groupRoleWhat they receive
IntubationOtherIntubation will take place according to our local standard protocol for nasal intubation using non-invasive positive pressure ventilation (NIPPV) delivered through a nasopharyngeal tube. The intubation will be video-recorded to provide a clear view of the procedure and the pulse oximeter displaying the peripheral oxygen saturation (SpO2 [%]) and heart rate (HR [bpm]).
Receives: Procedure: Intubation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful nasal intubation at the first intubation attempt without physiological instability

    Number of successful intubations at the first intubation attempt. Physiological instability is defined as the absolute decrease in SpO2 of >20% from baseline and/or bradycardia with a heart rate of <100 bpm for any duration during the first intubation attempt. Baseline is defined as the time immediately before removal of face mask or prong for placement of the nasopharyngeal tube. The intubation starts and ends with the insertion and removal of the laryngoscope blade beyond the infant's lip.

    Measured: first intubation attempt

Secondary outcomes (19)

  1. Incidence of desaturation

    Number of desaturations (SpO2 <80 %) between baseline and the begin of the first intubation attempt

    Measured: baseline to begin of first intubation attempt

  2. Incidence of bradycardia

    Number of bradycardia (HR <100 bpm) between baseline and the begin of the first intubation attempt

    Measured: baseline to begin of first intubation attempt

  3. Peripheral oxygen saturation

    Mean oxygen saturation over time between baseline and the begin of the first intubation attempt, SpO2 [%]

    Measured: baseline to begin of first intubation attempt

  4. Heart rate

    Mean heart rate over time between baseline and the begin of the first intubation attempt, HR [bpm]

    Measured: baseline to begin of first intubation attempt

  5. Incidence of desaturation

    Number of desaturations (SpO2 <80 %) during first intubation attempt

    Measured: first intubation attempt

  6. Incidence of bradycardia

    Number of bradycardia (Hf <100 bpm) during first intubation attempt

    Measured: first intubation attempt

  7. Peripheral oxygen saturation

    Mean oxygen saturation over time during first intubation attempt, SpO2 [%]

    Measured: first intubation attempt

  8. Heart rate

    Mean heart rate over time during first intubation attempt, HR [bpm]

    Measured: first intubation attempt

  9. Time to desaturation during first intubation attempt

    Time [sec] between time zero and desaturation (SpO2 <80%) during the first intubation attempt. Time zero is defined as the time the laryngoscope is inserted past the infant's lips for the first intubation attempt.

    Measured: first intubation attempt

  10. Duration of desaturation during first intubation attempt

    Time of SpO2 spent below 80% during the first intubation attempt

    Measured: first intubation attempt

  11. Time to bradycardia during first intubation attempt

    Time [sec] between time zero and bradycardia (HR <100 bpm) during the first intubation attempt.

    Measured: first intubation attempt

  12. Duration of bradycardia during first intubation attempt

    Time of HR spent below 100 bpm during the first intubation attempt

    Measured: first intubation attempt

  13. Duration of intubation attempt(s)

    Time from baseline to successful intubation including all intubation attempts, [sec]

    Measured: overall intubation procedure

  14. Number of intubation attempts

    Total number of intubation attempts to successful intubation, [n]

    Measured: overall intubation procedure

  15. Number of disconnections from ventilator circuit

    Total number of disconnections from ventilator circuit between baseline and end of intubation attempt(s), [n]

    Measured: overall intubation procedure

  16. Incidence of cardiac compressions

    Incidence of cardiac compressions within one hour after first intubation attempt, [n]

    Measured: Within one hour of first intubation attempt

  17. Incidence of epinephrine administration

    Incidence of epinephrine administration within one hour after first intubation attempt, [n]

    Measured: Within one hour of first intubation attempt

  18. Incidence of pneumothorax requiring drainage

    Incidence of pneumothorax requiring drainage within 24 hours after first intubation attempt, [n]

    Measured: Within 24 hours of first intubation attempt

  19. Incidence of death

    Incidence of death within 24 hours after first intubation attempt, [n]

    Measured: Within 24 hours of first intubation attempt

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start31 Mar 2024
  3. Primary completion5 Oct 2025
  4. Study completion5 Oct 2025

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
prospective single-center study
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06139809
Sponsor's protocol ID
IntubAID
Acronym
IntubAID
Status last verified
Nov 2025
First submitted
14 Nov 2023
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hodgson KA, Owen LS, Kamlin COF, Roberts CT, Newman SE, Francis KL, Donath SM, Davis PG, Manley BJ. Nasal High-Flow Therapy during Neonatal Endotracheal Intubation. N Engl J Med. 2022 Apr 28;386(17):1627-1637. doi: 10.1056/NEJMoa2116735.

    PubMed 35476651

  • Kothari R, Hodgson KA, Davis PG, Thio M, Manley BJ, O'Currain E. Time to desaturation in preterm infants undergoing endotracheal intubation. Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):603-607. doi: 10.1136/archdischild-2020-319509. Epub 2021 Apr 30.

    PubMed 33931396

  • Foglia EE, Ades A, Sawyer T, Glass KM, Singh N, Jung P, Quek BH, Johnston LC, Barry J, Zenge J, Moussa A, Kim JH, DeMeo SD, Napolitano N, Nadkarni V, Nishisaki A; NEAR4NEOS Investigators. Neonatal Intubation Practice and Outcomes: An International Registry Study. Pediatrics. 2019 Jan;143(1):e20180902. doi: 10.1542/peds.2018-0902. Epub 2018 Dec 11.

    PubMed 30538147

  • Kamlin CO, O'Connell LA, Morley CJ, Dawson JA, Donath SM, O'Donnell CP, Davis PG. A randomized trial of stylets for intubating newborn infants. Pediatrics. 2013 Jan;131(1):e198-205. doi: 10.1542/peds.2012-0802. Epub 2012 Dec 10.

    PubMed 23230069

  • Lemyre B, Deguise MO, Benson P, Kirpalani H, Ekhaguere OA, Davis PG. Early nasal intermittent positive pressure ventilation (NIPPV) versus early nasal continuous positive airway pressure (NCPAP) for preterm infants. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD005384. doi: 10.1002/14651858.CD005384.pub3.

    PubMed 37466143

Questions about this trial

What is this clinical trial studying?

A study testing Intubation in people with Infant, Newborn, Diseases and Intubation Complication, run by University of Zurich at 1 site in Switzerland.

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 5 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 18 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 Switzerland. 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?

Successful nasal intubation at the first intubation attempt without physiological instability (time frame: first intubation attempt). 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 NCT06139809, which also lists 5 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 18 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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