Safer breathing tube placement for newborns in the NICU
Optimizing Tracheal Intubation Outcomes and Neonatal Safety (OPTION SAFE)
This project uses a personalized safety bundle to try to reduce complications when placing breathing tubes in critically ill newborns in neonatal intensive care units.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Children's Hosp of Philadelphia NIH-funded |
| Lab location | 1 site (Philadelphia, United States) |
| Project ID | NIH-11115750 on NIH RePORTER |
What this research studies
From a parent's perspective, hospitals will introduce a Personalized Intubation Safety (PINS) Bundle that standardizes planning, premedication, provider assignment, and use of video laryngoscopy before newborns are intubated. The bundle was developed from prior work and tested in a single-center pilot and will now be rolled out across eight NICUs using a randomized stepped-wedge design while collecting data through the NEAR4NEOS registry. The study compares rates of adverse intubation-associated events, severe events, oxygen desaturations, and repeated attempts before and after the bundle is introduced. Staff training, checklists, and real-world workflow changes are included so the bundle can be used during routine and emergency neonatal care.
Who could benefit from this research
Good fit: Ideal candidates are newborns treated in participating NICUs who require tracheal intubation for respiratory failure, resuscitation, or other clinical indications.
Not a fit: Infants who never require intubation, those treated at nonparticipating hospitals, or cases where immediate emergency care prevents bundle implementation may not receive direct benefit.
Why it matters
Potential benefit: If successful, this approach could lower serious intubation complications, reduce failed extubations, and improve short-term outcomes and safety for infants who need breathing tubes.
How similar studies have performed: A single-center pilot of the PINS bundle showed a sustained 66% reduction in severe intubation-related adverse events, though this multicenter randomized rollout is a larger, newer test.
Where this research is happening
Philadelphia, United States
- Children's Hosp of Philadelphia — Philadelphia, United States (Active)
Researchers
- Principal investigator: Foglia, Elizabeth — Children's Hosp of Philadelphia
- Study coordinator: Foglia, Elizabeth
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.