Optimizing Tracheal Intubation Outcomes and Neonatal Safety
NCT ID: NCT05838690
Last Updated: 2025-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3000 participants
INTERVENTIONAL
2023-04-01
2027-06-30
Brief Summary
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Detailed Description
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This is a pragmatic stepped wedge cluster randomized trial of NICU patients who are intubated across 8 participating hospitals to determine if the PINS Bundle, compared to no PINS Bundle, reduces the incidence of adverse tracheal intubation associated events.
The primary objective of this study is to determine the effectiveness of the PINS Bundle to decrease adverse TI safety events. The secondary objectives are 1) to evaluate if the impact of the PINS Bundle on adverse TI safety events varies based on provider skill, and 2) to determine the impact of the PINS Bundle on NICU clinical outcomes of extubation failure, duration of intubation, NICU mortality, and intraventricular hemorrhage.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Pre-Intervention Phase
NICU Patients who are intubated without the PINS Bundle.
No interventions assigned to this group
Post-intervention Phase
NICU Patients who are intubated after unit implementation of the PINS Bundle
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Year
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Elizabeth Foglia, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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University of Arkansas Medical Sciences
Little Rock, Arkansas, United States
University of Colorado - Denver
Denver, Colorado, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
Dartmouth-Hitchcock Clinic
Lebanon, New Hampshire, United States
WakeMed Health & Hospitals
Raleigh, North Carolina, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Washington
Seattle, Washington, United States
CHU Sainte-Justine
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-019975
Identifier Type: -
Identifier Source: org_study_id
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