Safer breathing tube placement for newborns in the NICU
Official title: Optimizing Tracheal Intubation Outcomes and Neonatal Safety (OPTION SAFE)
Funded at Children's Hosp of Philadelphia · NIH-11115750 · Data updated 2026-11-12
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 start | September 1, 2022 |
| Project end | June 30, 2027 |
| Funding year | 2025 |
| Award (this year) | $727,498 |
| NIH project number | 5R01HD106996-04 |
| Project ID | NIH-11115750 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are newborns treated in participating NICUs who require tracheal intubation for respiratory failure, resuscitation, or other clinical indications.
✕Less likely to help
Infants who never require intubation, those treated at nonparticipating hospitals, or cases where immediate emergency care prevents bundle implementation may not receive direct benefit.
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.
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 gone: 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
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Children's Hosp of Philadelphia
Philadelphia, United States Active
Researchers
- Principal investigator: Foglia, Elizabeth — Children's Hosp of Philadelphia
- Study coordinator: Foglia, Elizabeth
Related research
Other NIH-funded projects on the same topics.
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IVOS Medical: Intubation, Optimized.
A small NIH-funded project aims to improve endotracheal intubation, a life-saving airway procedure, by making it safer and more reliable for adults in emergency and critical care settings.
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Personalized Intubation Safety for Sick Neonates
A new approach helps doctors safely manage breathing tube placement in critically ill newborns, aiming to reduce complications and improve outcomes.
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Pre-intubation checklist to make emergency breathing tube placement safer for injured children
Using a pre-intubation checklist and support tools to help emergency teams place breathing tubes more safely in children after traumatic injury.
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Improved breathing tube placement
This project is creating a better video tool to help doctors place breathing tubes more quickly and safely for adults needing emergency or surgical airway care.
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A new endotracheal tube with optical sensors to improve intubation safety
This study is testing a new type of breathing tube that has special sensors to help doctors place it correctly and keep an eye on it during procedures, making it safer for patients who need help breathing.
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Improving the safety and effectiveness of emergency intubation procedures.
This study is looking at ways to make it easier and safer for doctors to use a special camera tool during emergency intubation, by creating a disposable cover that keeps the camera clean, so patients can have better care when they need it most.
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.