Providing oxygen during intubation for newborns in the NICU
Apneic Oxygenation to Prevent Oxygen Desaturation During Intubation in the NICU
This study is testing if giving extra oxygen to newborns during intubation can help keep their oxygen levels stable compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 0 Days to 365 Days |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05451953 on ClinicalTrials.gov |
What this trial studies
This trial investigates the use of apneic oxygenation in infants undergoing tracheal intubation in the NICU, aiming to reduce oxygen desaturation during the procedure. Infants who meet specific criteria will be randomly assigned to receive either apneic oxygenation or standard care without respiratory support. The study will be conducted at two prominent hospitals in Philadelphia, focusing on improving outcomes for neonates facing respiratory failure. By comparing the two approaches, the trial seeks to determine the effectiveness of apneic oxygenation in maintaining oxygen levels during intubation.
Who should consider this trial
Good fit: Ideal candidates are infants aged 28 weeks or older who require intubation in the NICU.
Not a fit: Patients with critical airway anomalies or unstable hemodynamics will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve oxygenation and reduce complications during intubation in critically ill newborns.
How similar studies have performed: Previous studies have shown promising results with apneic oxygenation in older children and adults, suggesting potential applicability in neonates.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth Foglia, MD, MSCE — University of Pennsylvania
- Study coordinator: Heidi Herrick, MD, MSCE
- Email: herrickh@chop.edu
- Phone: 267-408-6146
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.