Recruiting

Tracheal Intubation

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT05838690

Conditions

Infant

Intubation Complication

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Personalized Intubation Safety (PINS) Bundle

Study Details

Brief 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

Study ID

NCT05838690

Start date

Apr 1, 2023

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Inclusion Criteria:

Infants undergoing tracheal intubation in the neonatal intensive care unit (NICU)

Exclusion Criteria:

Endotracheal tube exchanges, as this represents a distinct procedure.

Study Design

Enrollment

3000 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Pre-Intervention Phase

NICU Patients who are intubated without the PINS Bundle.

active comparator: Post-intervention Phase

NICU Patients who are intubated after unit implementation of the PINS Bundle

Interventions

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

Primary outcome measure

  • Tracheal intubation associated event (TIAE) [ Time Frame: During the intubation procedure, on average 20 minutes ]

Central Contacts and Locations

Central contacts

Elizabeth Foglia, MD

215-590-1000foglia@chop.edu

Hayley Buffman, MPH

215-590-1000buffmanh@chop.edu

Locations

University of Arkansas Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Shuk-Mei Ho, MD

501-686-5391shukmeiho@uams.edu

Principal Investigator:

Jennifer Rumpel, MD

University of Colorado - Denver

Recruiting

Denver, Colorado, United States, 80204

Contacts

Deborah Barnard

303-724-7628Deborah.barnard@ucdenver.edu

Principal Investigator:

Rebecca Shay, MD, MAS

Yale-New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Monika Lau, MEd

203-737-4434Monika.lau@yale.edu

Principal Investigator:

Lindsay Johnston, MD, MEd

Dartmouth-Hitchcock Clinic

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Kelly Stevens

207-415-7180Kelly.j.stevens@hitchcock.org

Principal Investigator:

Tyler Hartman, MD

WakeMed Health & Hospitals

Recruiting

Raleigh, North Carolina, United States, 27610

Contacts

Catherine Kilday

919-350-7335ckilday@wakemed.org

Principal Investigator:

Stephen DeMeo, DO

Penn State Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Rafael Santos, MS, CIP

814-865-4295Rms7210@psu.edu

Principal Investigator:

Kristen Glass, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Johanna Salmonson

206-543-4464salmoj@uw.edu

Principal Investigator:

Ivana Brajkovic, MD, MPH

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Keywords

  • Infant
  • Intubation
  • NICU
  • Safety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-03-04.