Noninvasive Positive Pressure Ventilation During Neonatal Nasal Intubation (IntubAID)

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.

Study Overview

• Status: Completed
• Conditions: Infant, Newborn, Diseases; Intubation Complication
• Intervention / Treatment: Procedure: Intubation

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intubation; Intubation 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]).	Procedure: Intubation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	first intubation attempt

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of desaturation	Number of desaturations (SpO2 <80 %) between baseline and the begin of the first intubation attempt	baseline to begin of first intubation attempt
Incidence of bradycardia	Number of bradycardia (HR <100 bpm) between baseline and the begin of the first intubation attempt	baseline to begin of first intubation attempt
Peripheral oxygen saturation	Mean oxygen saturation over time between baseline and the begin of the first intubation attempt, SpO2 [%]	baseline to begin of first intubation attempt
Heart rate	Mean heart rate over time between baseline and the begin of the first intubation attempt, HR [bpm]	baseline to begin of first intubation attempt
Incidence of desaturation	Number of desaturations (SpO2 <80 %) during first intubation attempt	first intubation attempt
Incidence of bradycardia	Number of bradycardia (Hf <100 bpm) during first intubation attempt	first intubation attempt
Peripheral oxygen saturation	Mean oxygen saturation over time during first intubation attempt, SpO2 [%]	first intubation attempt
Heart rate	Mean heart rate over time during first intubation attempt, HR [bpm]	first intubation attempt
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.	first intubation attempt
Duration of desaturation during first intubation attempt	Time of SpO2 spent below 80% during the first intubation attempt	first intubation attempt
Time to bradycardia during first intubation attempt	Time [sec] between time zero and bradycardia (HR <100 bpm) during the first intubation attempt.	first intubation attempt
Duration of bradycardia during first intubation attempt	Time of HR spent below 100 bpm during the first intubation attempt	first intubation attempt
Duration of intubation attempt(s)	Time from baseline to successful intubation including all intubation attempts, [sec]	overall intubation procedure
Number of intubation attempts	Total number of intubation attempts to successful intubation, [n]	overall intubation procedure
Number of disconnections from ventilator circuit	Total number of disconnections from ventilator circuit between baseline and end of intubation attempt(s), [n]	overall intubation procedure
Incidence of cardiac compressions	Incidence of cardiac compressions within one hour after first intubation attempt, [n]	Within one hour of first intubation attempt
Incidence of epinephrine administration	Incidence of epinephrine administration within one hour after first intubation attempt, [n]	Within one hour of first intubation attempt
Incidence of pneumothorax requiring drainage	Incidence of pneumothorax requiring drainage within 24 hours after first intubation attempt, [n]	Within 24 hours of first intubation attempt
Incidence of death	Incidence of death within 24 hours after first intubation attempt, [n]	Within 24 hours of first intubation attempt

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Study Chair: Dirk Bassler, MD, Newborn Research, Depatrment of Neonatology, University Hospital and University of Zurich

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2024
• Primary Completion (Actual): October 5, 2025
• Study Completion (Actual): October 5, 2025

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Non-invasive ventilation; Intubation; Continuous positive airway pressure; Mechanical ventilation; Non-invasive positive pressure ventilation; Physiological stability
• Additional Relevant MeSH Terms: Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Investigative Techniques; Therapeutics; Intubation
• Other Study ID Numbers: IntubAID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No