# Optimizing Tracheal Intubation Outcomes and Neonatal Safety (OPTION SAFE)

> **NIH NIH R01** · CHILDREN'S HOSP OF PHILADELPHIA · 2024 · $722,379

## Abstract

PROJECT SUMMARY
Tracheal Intubation (TI) is a common life-saving intervention for resuscitation of critically ill infants in Neonatal
Intensive Care Units (NICUs). Through our NICHD-funded NICU multicenter registry (National Emergency
Airway Registry for Neonates: NEAR4NEOS), we have identified that Adverse TI Associated Events (TIAEs)
occur in 22% TIs, severe TIAES occur in 4% TIs, and multiple attempts occur in 23% TIs. Oxygen
desaturations (captured separately from TIAEs) are frequent and pronounced, with a mean 28% decline in
SpO2 during neonatal TI. Moreover, neonates who experienced adverse TIAEs were at higher risk of
extubation failure and NICU mortality.
We have identified key factors strongly associated with adverse TIAEs: 1) patient risk, 2) provider skill, 3)
premedication with paralysis, and 4) video laryngoscopy. We have developed, refined, and tested a
Personalized Intubation Safety (PINS) Bundle aimed at addressing these factors and prompting a prospective
plan for TI management. The prototype Safety Bundle resulted in a sustained 66% reduction in severe TI
adverse events in our pilot single center study.
In this proposal, we will perform a pragmatic stepped wedge cluster randomized trial across 8 NEAR4NEOS
NICUs to assess the impact of the Personalized Intubation Bundle on TI safety events. The timing of
introducing the Bundle intervention will be randomized at the NICU site level. Our primary outcome is adverse
TIAEs; secondary outcomes are severe TIAEs, multiple (>2) attempts, and magnitude of oxygen desaturation.
We will test whether there is a significant variability in the treatment effect of the PINS Bundle based on the
airway provider skill. This will provide important information about the impact of the Bundle intervention and its
components for novice vs. experienced providers, which will help NICUs to contextualize study findings.
Finally, we will explore the impact of the PINS Bundle intervention on relevant NICU patient outcomes,
including extubation failure, duration of mechanical ventilation, intraventricular hemorrhage, and NICU
mortality.
Upon successful completion of this project, we will establish the effectiveness of a prospective Personalized
Intubation Safety Bundle to reduce adverse events, multiple attempts and oxygen desaturation during neonatal
TI. These results will generate a paradigm shift to improve neonatal intubation procedural safety.

## Key facts

- **NIH application ID:** 10852921
- **Project number:** 5R01HD106996-03
- **Recipient organization:** CHILDREN'S HOSP OF PHILADELPHIA
- **Principal Investigator:** Elizabeth Foglia
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $722,379
- **Award type:** 5
- **Project period:** 2022-09-01 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10852921

## Citation

> US National Institutes of Health, RePORTER application 10852921, Optimizing Tracheal Intubation Outcomes and Neonatal Safety (OPTION SAFE) (5R01HD106996-03). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10852921. Licensed CC0.

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