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Providing Oxygen During Intubation in the NICU Trial

Providing Oxygen During Intubation in the NICU Trial

Recruiting
365 years and younger
All
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  1. Infants ≥28 weeks corrected gestational age
  2. Undergoing intubation in the NICU
  3. Pre-medication (including paralytic) administered

Exclusion Criteria:

  1. Critical Airway or Airway Anomaly
  2. Unstable hemodynamics (i.e. active resuscitation)
  3. Unable to achieve SpO2 ≥90% prior to intubation attempt
  4. Intubation performed by Non-NICU provider (i.e. anesthesiology or ENT)
  5. Unrepaired congenital diagrammatic hernia
  6. Tracheal esophageal fistula within 2 weeks of repair
  7. Tracheostomy
  8. Previous enrollment in the trial
  9. Nasal intubation
  10. COVID person under investigation (PUI) or COVID positive
  11. Cyanotic heart disease
  12. Receiving Extracorporeal Membrane Oxygenation support
  13. Conjoined twins

Study details
    Neonatal Respiratory Failure
    Tracheal Intubation Morbidity

NCT05451953

University of Pennsylvania

4 June 2025

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