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Behavioural Intervention
PINS Bundle for Infant Intubation Safety (OPTION SAFE Trial)
N/A
Recruiting
Led By Elizabeth Foglia, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, on average 90 days
Awards & highlights
OPTION SAFE Trial Summary
This trial will test a tool to help make intubation safer in NICUs, with the goal of improving patient outcomes.
Who is the study for?
This trial is for infants who need a tracheal intubation procedure in the neonatal intensive care unit (NICU). It's not specified what conditions exclude an infant from participating, but typically those with certain health issues may not be eligible.Check my eligibility
What is being tested?
The study is testing the Personalized INtubation Safety (PINS) Bundle, which is a planning tool designed to improve the safety and outcomes of intubation procedures in newborns within NICUs.See study design
What are the potential side effects?
Since this trial involves a procedural planning tool rather than a drug or medical device, traditional side effects are not applicable. However, there could be risks associated with any changes to standard intubation practices.
OPTION SAFE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, on average 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, on average 90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tracheal intubation associated event (TIAE)
Secondary outcome measures
Duration of mechanical ventilation
Magnitude of oxygen desaturation
NICU Mortality
+4 moreOPTION SAFE Trial Design
2Treatment groups
Active Control
Group I: Pre-Intervention PhaseActive Control1 Intervention
NICU Patients who are intubated without the PINS Bundle.
Group II: Post-intervention PhaseActive Control1 Intervention
NICU Patients who are intubated after unit implementation of the PINS Bundle
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Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
710 Previous Clinical Trials
8,585,964 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,978 Previous Clinical Trials
2,677,885 Total Patients Enrolled
Elizabeth Foglia, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
1 Previous Clinical Trials
21 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had an endotracheal tube exchange.My infant needs a breathing tube in the NICU.
Research Study Groups:
This trial has the following groups:- Group 1: Pre-Intervention Phase
- Group 2: Post-intervention Phase
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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