Improving safety of tracheal intubation in newborns
Official title: Optimizing Tracheal Intubation Outcomes and Neonatal Safety
Run by Children's Hospital of Philadelphia · NCT05838690 · Data updated 2026-11-12
This study is testing a new safety plan for intubating newborns in NICUs to see if it can lower the risk of complications during the procedure.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 1 Year |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 8 sites (Little Rock, Arkansas and 7 other locations) |
| Status | Recruiting |
| Started | April 1, 2023 |
| Main results expected | June 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | March 4, 2026 |
| Trial ID | NCT05838690 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants who require tracheal intubation in a neonatal intensive care unit.
✕Probably not a fit
Patients undergoing endotracheal tube exchanges will not benefit from this study as it focuses on initial intubation procedures.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of a Personalized Intubation Safety (PINS) Bundle designed to enhance the safety and outcomes of tracheal intubation procedures in neonatal intensive care units (NICUs). The PINS Bundle incorporates a personalized approach that includes patient risk assessment, treatment thresholds, premedication strategies, equipment recommendations, and provider selection. Conducted as a pragmatic stepped wedge cluster randomized trial across eight hospitals, the study aims to compare the incidence of adverse events during intubation between those using the PINS Bundle and those who do not. The primary goal is to reduce complications associated with intubation in infants.
Why it matters
Potential benefit: If successful, this study could significantly improve the safety and clinical outcomes of tracheal intubation in neonates.
How similar studies have gone: Other studies have shown promising results with personalized approaches to medical procedures, suggesting potential success for this novel intervention.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Infants undergoing tracheal intubation in the neonatal intensive care unit (NICU) Exclusion Criteria: Endotracheal tube exchanges, as this represents a distinct procedure.
Where it's running
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University of Arkansas Medical Sciences
Little Rock, Arkansas, United States Recruiting -
University of Colorado - Denver
Denver, Colorado, United States Recruiting -
Yale-New Haven Hospital
New Haven, Connecticut, United States Recruiting -
Dartmouth-Hitchcock Clinic
Lebanon, New Hampshire, United States Recruiting -
WakeMed Health & Hospitals
Raleigh, North Carolina, United States Recruiting -
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States Recruiting
Show 2 more locations
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University of Washington
Seattle, Washington, United States Recruiting -
CHU Sainte-Justine
Montreal, Quebec, Canada Active not recruiting
Study contacts
- Principal investigator: Elizabeth Foglia, MD — Children's Hospital of Philadelphia
- Study coordinator: Elizabeth Foglia, MD
- Email: foglia@chop.edu
- Phone: 215-590-1000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.