InfantOPTION SAFENCT05838690
Optimizing Tracheal Intubation Outcomes and Neonatal Safety
A study testing Personalized Intubation Safety (PINS) Bundle in people with Infant and Intubation Complication, run by Children's Hospital of Philadelphia at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Infant, Intubation Complication
- What is being tested?
- Personalized Intubation Safety (PINS) Bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Apr 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants undergoing tracheal intubation in the neonatal intensive care unit (NICU)
Who cannot join
- Endotracheal tube exchanges, as this represents a distinct procedure.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
University of Colorado - Denver
Denver, Colorado, 80204
Deborah Barnard, 303-724-7628, Deborah.barnard@ucdenver.edu
Rebecca Shay, MD, MAS
- Recruiting
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Rafael Santos, MS, CIP, 814-865-4295, Rms7210@psu.edu
Kristen Glass, MD
- Recruiting
Dartmouth-Hitchcock Clinic
Lebanon, New Hampshire, 03756
Kelly Stevens, 207-415-7180, Kelly.j.stevens@hitchcock.org
Tyler Hartman, MD
- Recruiting
University of Arkansas Medical Sciences
Little Rock, Arkansas, 72205
Shuk-Mei Ho, MD, 501-686-5391, shukmeiho@uams.edu
Jennifer Rumpel, MD
- Recruiting
Yale-New Haven Hospital
New Haven, Connecticut, 06510
Monika Lau, MEd, 203-737-4434, Monika.lau@yale.edu
Lindsay Johnston, MD, MEd
- Recruiting
WakeMed Health & Hospitals
Raleigh, North Carolina, 27610
Catherine Kilday, 919-350-7335, ckilday@wakemed.org
Stephen DeMeo, DO
- Recruiting
University of Washington
Seattle, Washington, 98195
Johanna Salmonson, 206-543-4464, salmoj@uw.edu
Ivana Brajkovic, MD, MPH
Canada1 site
- Active, not recruiting
CHU Sainte-Justine
Montreal, Quebec, QC H3T 1C5
About this study
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.
Read the detailed description
Tracheal intubation (TI) in the neonatal intensive care unit (NICU) is frequently complicated by adverse safety outcomes such as adverse tracheal intubation associated events, multiple TI attempts, and oxygen desaturation. Investigators have developed, refined, and tested a Personalized INtubation Safety (PINS) Bundle that targets a prospective and individualized approach to TI planning and management. The Prospective Intubation Safety (PINS) Bundle addresses 5 core evidence-based domains that are individualized to the patient to develop a prospective, personalized and comprehensive multidisciplinary TI plan: (1) patient risk assessment; (2) treatment threshold for intubation; (3) premedication (promoting paralytic medication); (4) equipment (promoting video laryngoscope); (5) provider selection and escalation plan.
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
- Infant, Intubation Complication
- Being tested
- Personalized Intubation Safety (PINS) Bundle
- Keywords
- Infant, Intubation, NICU, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Intubation Safety (PINS) BundleOther
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Personalized Intubation Safety (PINS) Bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the intubation procedure, on average 20 minutes
Secondary outcomes (7)
Severe TIAE
Any severe TIAE, defined by National Emergency Airway Registry for Neonates (NEAR4NEOS) Operational Definitions
Measured: During the intubation procedure, on average 20 minutes
Magnitude of oxygen desaturation
Difference between highest oxygen saturation (SpO2) value immediately before first intubation attempt and lowest value at any point during the procedure
Measured: During the intubation procedure, on average 20 minutes
Number of subjects with multiple intubation attempts (>2 attempts)
More than 2 intubation attempts
Measured: During the intubation procedure, on average 20 minutes
Duration of mechanical ventilation
Duration of mechanical ventilation after the immediate intubation encounter
Measured: Through study completion, on average 90 days
Number of subjects requiring reintubation within 24 hours of extubation
Need for reintubation within 24 hours of extubation from the course of ventilation immediately following the intubation encounter
Measured: Up to 24 hours after extubation
Number of subjects with Intraventricular hemorrhage
Any intraventricular hemorrhage and grade on head ultrasound, assessed for at risk preterm infants
Measured: Up to 7 days after birth
NICU Mortality
Death before NICU discharge
Measured: Through study completion, on average 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Apr 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfantStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Foglia, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838690
- Sponsor's protocol ID
- 22-019975
- Other IDs
- R01HD106996
- Acronym
- OPTION SAFE
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Tracheal Intubation Outcomes and Neonatal Safety
- ClinicalTrials.gov ID
- NCT05838690
- Acronym / sponsor ID
- OPTION SAFE / 22-019975
- Conditions
- Infant, Intubation Complication
- Keywords
- Infant, Intubation, NICU, Safety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tracheal intubation (TI) in the neonatal intensive care unit (NICU) is frequently complicated by adverse safety outcomes such as adverse tracheal intubation associated events, multiple TI attempts, and oxygen desaturation. Investigators have developed, refined, and tested a Personalized INtubation Safety (PINS) Bundle that targets a prospective and individualized approach to TI planning and management. The Prospective Intubation Safety (PINS) Bundle addresses 5 core evidence-based domains that are individualized to the patient to develop a prospective, personalized and comprehensive multidisciplinary TI plan: (1) patient risk assessment; (2) treatment threshold for intubation; (3) premedication (promoting paralytic medication); (4) equipment (promoting video laryngoscope); (5) provider selection and escalation plan.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention Phase | No intervention | –NICU Patients who are intubated without the PINS Bundle. |
| Post-intervention Phase | Active comparator | Other: Personalized Intubation Safety (PINS) BundleNICU Patients who are intubated after unit implementation of the PINS Bundle |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants undergoing tracheal intubation in the neonatal intensive care unit (NICU)
Key exclusion criteria (1 listed)
- Endotracheal tube exchanges, as this represents a distinct procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Intubation Safety (PINS) BundleAlso: PINS BundleThe 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 | Post-intervention Phase |
Primary outcome
Tracheal intubation associated event (TIAE)
Time frame: During the intubation procedure, on average 20 minutes
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
7 secondary outcomes
Severe TIAE
Time frame: During the intubation procedure, on average 20 minutes
Magnitude of oxygen desaturation
Time frame: During the intubation procedure, on average 20 minutes
Number of subjects with multiple intubation attempts (>2 attempts)
Time frame: During the intubation procedure, on average 20 minutes
Duration of mechanical ventilation
Time frame: Through study completion, on average 90 days
Number of subjects requiring reintubation within 24 hours of extubation
Time frame: Up to 24 hours after extubation
Number of subjects with Intraventricular hemorrhage
Time frame: Up to 7 days after birth
NICU Mortality
Time frame: Through study completion, on average 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Foglia, MD principal investigator
Children's Hospital of Philadelphia
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Intubation Safety (PINS) Bundle in people with Infant and Intubation Complication, run by Children's Hospital of Philadelphia at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Foglia, MD (215-590-1000, foglia@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracheal intubation associated event (TIAE) (time frame: During the intubation procedure, on average 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026; AzTrials last refreshed its copy on 1 Nov 2026.