Actively Recruiting
Providing Oxygen During Intubation in the NICU Trial
Led by University of Pennsylvania · Updated on 2025-06-18
110
Participants Needed
1
Research Sites
240 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Providing Oxygen During Intubation in the NICU Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants at least 28 weeks corrected gestational age
- Undergoing intubation in the NICU
- Pre-medication, including paralytic, administered prior to intubation
You will not qualify if you...
- Critical airway or airway anomaly
- Unstable hemodynamics such as active resuscitation
- Unable to reach oxygen saturation (SpO2) of 90% before intubation attempt
- Intubation performed by a non-NICU provider (e.g., anesthesiology or ENT)
- Unrepaired congenital diaphragmatic hernia
- Tracheal esophageal fistula within 2 weeks of repair
- Presence of tracheostomy
- Previous enrollment in this trial
- Nasal intubation
- COVID-19 person under investigation (PUI) or COVID-19 positive
- Cyanotic heart disease
- Receiving extracorporeal membrane oxygenation (ECMO) support
- Conjoined twins
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
H
Heidi Herrick, MD, MSCE
CONTACT
E
Elizabeth Foglia, MD, MSCE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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