NCT06139809

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

March 31, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

November 14, 2023

Last Update Submit

November 14, 2025

Conditions

Infant, Newborn, DiseasesIntubation Complication

Keywords

IntubationNon-invasive ventilationNon-invasive positive pressure ventilationContinuous positive airway pressureMechanical ventilationPhysiological stability

Outcome Measures

Primary Outcomes (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.

    first intubation attempt

Secondary Outcomes (19)

  • Incidence of desaturation

    baseline to begin of first intubation attempt

  • Incidence of bradycardia

    baseline to begin of first intubation attempt

  • Peripheral oxygen saturation

    baseline to begin of first intubation attempt

  • Heart rate

    baseline to begin of first intubation attempt

  • Incidence of desaturation

    first intubation attempt

  • +14 more secondary outcomes

Study Arms (1)

Intubation

OTHER

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

Interventions

IntubationPROCEDURE

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.

Intubation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, Switzerland

Location

Related Publications (5)

  • 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.

    PMID: 35476651BACKGROUND

  • 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.

    PMID: 33931396BACKGROUND

  • 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.

    PMID: 30538147BACKGROUND

  • 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.

    PMID: 23230069BACKGROUND

  • 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.

    PMID: 37466143BACKGROUND

MeSH Terms

Conditions

Infant, Newborn, Diseases

Interventions

Intubation

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Officials

  • Dirk Bassler, MD

    Newborn Research, Depatrment of Neonatology, University Hospital and University of Zurich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: prospective single-center study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 18, 2023

Study Start

March 31, 2024

Primary Completion

October 5, 2025

Study Completion

October 5, 2025

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)