NCT05838690

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
2 countries

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Apr 2023Dec 2027

First Submitted

Initial submission to the registry

March 14, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

4.2 years

First QC Date

March 14, 2023

Last Update Submit

March 3, 2026

Conditions

InfantIntubation Complication

Keywords

InfantIntubationNICUSafety

Outcome Measures

Primary Outcomes (1)

  • Tracheal intubation associated event (TIAE)

    Any adverse tracheal intubation associated event (TIAE) during the intubation encounter. In NEAR4NEOS database, a comprehensive group of adverse TIAEs are based on standard consensus-based definitions and classified as severe and non-severe

    During the intubation procedure, on average 20 minutes

Secondary Outcomes (7)

  • Severe TIAE

    During the intubation procedure, on average 20 minutes

  • Magnitude of oxygen desaturation

    During the intubation procedure, on average 20 minutes

  • Number of subjects with multiple intubation attempts (>2 attempts)

    During the intubation procedure, on average 20 minutes

  • Duration of mechanical ventilation

    Through study completion, on average 90 days

  • Number of subjects requiring reintubation within 24 hours of extubation

    Up to 24 hours after extubation

  • +2 more secondary outcomes

Study Arms (2)

Pre-Intervention Phase

NO INTERVENTION

NICU Patients who are intubated without the PINS Bundle.

Post-intervention Phase

ACTIVE COMPARATOR

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

Other: Personalized Intubation Safety (PINS) Bundle

Interventions

Personalized Intubation Safety (PINS) BundleOTHER

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

Also known as: PINS Bundle
Post-intervention Phase

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Endotracheal tube exchanges, as this represents a distinct procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Arkansas Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

University of Colorado - Denver

Denver, Colorado, 80204, United States

RECRUITING

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

Dartmouth-Hitchcock Clinic

Lebanon, New Hampshire, 03756, United States

RECRUITING

WakeMed Health & Hospitals

Raleigh, North Carolina, 27610, United States

RECRUITING

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

CHU Sainte-Justine

Montreal, Quebec, QC H3T 1C5, Canada

ACTIVE NOT RECRUITING

Study Officials

  • Elizabeth Foglia, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Foglia, MD

CONTACT

215-590-1000foglia@chop.edu

Hayley Buffman, MPH

CONTACT

215-590-1000buffmanh@chop.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2023

First Posted

May 1, 2023

Study Start

April 1, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

The PI will share unique research resources developed through this NIH-funded grant to enhance the value and further the advancement of research. The PI will make data available after study completion and in accordance with NIH policies. The data will only be provided to those investigators who agree to adhere to a signed research data use agreement. The execution of the agreement will require approval by the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB) or demonstration of IRB exemption per institutional policy. The data and associated documentation will be available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and does not identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed

Time Frame
Data will be available after study completion
Access Criteria
The data and associated documentation will be available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and does not identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed

Locations

US(7)CA(1)