Optimizing tracheal intubation outcomes and neonatal safety (option safe)

Active Project Grant Awarded Last action

Award ID
R01HD106996
Recipient
Awarding agency
Obligated
$5,064,339

Award facts

Completion date 86% complete
Place of performance
Philadelphia, PA 19104, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
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.

Transactions

Action Obligated Date
Amendment $698,802
Amendment $727,498
Amendment $722,379
Amendment $728,850
Amendment $728,850
Amendment $728,980
Original award $728,980

Subawards

Subrecipient Amount Awarded
Wakemed OPTION SAFE Statement of Work The site Pl along with their study team will be responsible for local IRB approval (through reliance agreements or submissions)… $41,000
The Regents Of The University Of Colorado OPTION SAFE Statement of Work The site PI along with their study team will be responsible for local IRB approval (through reliance agreements or submissions)… $43,000
Yale Univ $42,500
University Of Washington $43,000
Pennsylvania State University $69,000
University Of Arkansas For Medical Sciences $45,000
Dartmouth-Hitchcock Clinic Performance Objectives: The Subrecipient will: • Conduct study activities as per IRB‐approved protocol • Support Aims 1 and 2 of the overall project… $45,000

Quick answers

Who received award R01HD106996?

R01HD106996 was awarded to The Children's Hospital Of Philadelphia by National Institute of Child Health and Human Development (National Institutes of Health) on September 1, 2022.

How much is award R01HD106996 worth?

$5,064,339 has been obligated on R01HD106996.

On GovTribe

See this award's full record

  • Every transaction and subaward
  • The recipient's other awards and teaming partners
  • Similar grant awards
  • Ask GovTribe AI about this award
Try for free Login