Optimizing Tracheal Intubation Outcomes and Neonatal Safety
NCT05838690 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000
Last updated 2026-03-04
Summary
The purpose of the study is to assess the impact of a personalized intubation planning tool, the Personalized INtubation Safety (PINS) Bundle on intubation procedural safety and clinical outcomes among patients intubated in the neonatal intensive care unit (NICU) setting.
Conditions
- Infant
- Intubation Complication
Interventions
- OTHER
-
Personalized Intubation Safety (PINS) Bundle
The Personalized Intubation Safety (PINS) Bundle addresses 5 core domains that are individualized to the patient to develop a prospective, personalized and comprehensive multidisciplinary intubation plan: (1) patient risk assessment; (2) treatment threshold for intubation; (3) premedication (promoting paralytic premedication); (4) equipment (promoting video laryngoscope); (5) provider selection and escalation plan
Sponsors & Collaborators
-
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH -
Children's Hospital of Philadelphia
lead OTHER
Principal Investigators
-
Elizabeth Foglia, MD · Children's Hospital of Philadelphia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Max Age
- 1 Year
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-01
- Primary Completion
- 2027-06-30
- Completion
- 2027-12-31
Countries
- United States
- Canada
Study Locations
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