Improving safety of tracheal intubation in newborns
Optimizing Tracheal Intubation Outcomes and Neonatal Safety
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | N/A to 1 Year |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 8 sites (Little Rock, Arkansas and 7 other locations) |
| Trial ID | NCT05838690 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants who require tracheal intubation in a neonatal intensive care unit.
Not a fit: Patients undergoing endotracheal tube exchanges will not benefit from this study as it focuses on initial intubation procedures.
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 performed: Other studies have shown promising results with personalized approaches to medical procedures, suggesting potential success for this novel intervention.
Eligibility criteria
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 this trial is running
Little Rock, Arkansas and 7 other locations
- 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)
- 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
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.