NIH-funded research R01 grant

Personalized Intubation Safety for Sick Neonates

Official title: Optimizing Tracheal Intubation Outcomes and Neonatal Safety (OPTION SAFE)

Funded at Children's Hosp of Philadelphia · NIH-11380804 · Data updated 2026-11-12

A new approach helps doctors safely manage breathing tube placement in critically ill newborns, aiming to reduce complications and improve outcomes.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionChildren's Hosp of Philadelphia
NIH-funded
Lab location1 site (Philadelphia, United States)
Project startSeptember 1, 2022
Project endJune 30, 2027
Funding year2026
Award (this year)$698,802
NIH project number5R01HD106996-05
Project IDNIH-11380804 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates are infants in NICUs who require tracheal intubation and are at risk for airway-related complications.

Less likely to help

Very preterm infants or those not undergoing intubation may not directly benefit from this bundle.

What this research studies

This project tests a Safety Bundle called PINS to guide safer tracheal intubation in newborns across several NICUs. It builds on existing registry data to tailor interventions based on patient risk, provider skill, premedication, and use of video laryngoscopy. The study uses a pragmatic stepped-wedge design across eight NICUs to see if introducing the bundle lowers adverse events during intubation. Outcomes include adverse TI events, severe TI events, and extubation outcomes, with plans to monitor safety and effectiveness in real-world settings. If successful, the bundle could become a standard for reducing harm during neonatal airway management.

Why it matters

Potential benefit: If successful, the Safety Bundle could reduce harm and improve survival for newborns needing breathing support in the NICU.

How similar studies have gone: Previous pilot testing showed a 66% reduction in severe adverse events with the prototype Safety Bundle in a single center.

Where this research is happening

  • 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.

  • 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.

    NIH research Ivos Medical, INC. · Dana Point, United States · NIH-11389221

  • 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.

    NIH research Rhode Island Hospital · Providence, United States · NIH-11379071

  • 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.

    NIH research Ivos Medical, INC. · Dana Point, United States · NIH-11193843

  • Safer breathing tube placement for newborns in the NICU

    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.

    NIH research Children's Hosp of Philadelphia · Philadelphia, United States · NIH-11115750

  • 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.

    NIH research Endolynx INC · Jersey City, United States · NIH-11006824

  • 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.

    NIH research Ivos Medical, INC. · Dana Point, United States · NIH-10922562

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.