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Providing Oxygen During Intubation in the NICU Trial

NCT05451953 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-06-18

No results posted yet for this study

Summary

Tracheal intubation in the NICU is frequently complicated by severe oxygen desaturation. Apneic oxygenation, a method of applying free flowing oxygen via nasal cannula to apneic patients undergoing intubation, prevents or delays oxygen desaturation during intubation in adults and older children. We propose to enroll patients at two sites (Hospital of the University of Pennsylvania and Children's Hospital of Philadelphia) in a randomized trial in infants undergoing intubation in the NICU to determine if apneic oxygenation, compared with no respiratory support or oxygen during laryngoscopy and intubation attempts (standard care), reduces the magnitude of oxygen desaturation during tracheal intubation encounters.

Conditions

  • Neonatal Respiratory Failure
  • Tracheal Intubation Morbidity

Interventions

PROCEDURE

Apneic Oxygenation

Nasal cannula at a rate of 6L/min with 100% FiO2 during laryngoscopy and intubation attempt(s)

PROCEDURE

Standard of Care

No respiratory support during laryngoscopy and intubation attempt(s) (current standard of care)

Sponsors & Collaborators

Principal Investigators

  • Elizabeth Foglia, MD, MSCE · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
365 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05451953 on ClinicalTrials.gov