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PIBIS Decision Support for Infant Brain Injury (PIBIS Trial)

N/A

Waitlist Available

Led By Rachel Berger, MD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 30 days to less than 1 year

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to 6 months following hospital discharge

Awards & highlights

PIBIS Trial Summary

This trial is to see if the PIBIS can help identify which infants have a higher risk for AHT.

Who is the study for?

This trial is for infants under 1 year old who visit the UPMC Children's Hospital of Pittsburgh emergency department with certain symptoms like apnea, seizures, or fussiness. They must not have a fever over 38.3C and should be stable enough to not require immediate life-saving interventions.Check my eligibility

What is being tested?

The study is testing the use of the Pittsburgh Infant Brain Injury Score (PIBIS) as a tool in the emergency department compared to standard care. PIBIS aims to help identify infants at risk for abusive head trauma more effectively.See study design

What are the potential side effects?

Since this trial involves implementing a clinical decision support score rather than medication, there are no direct side effects from drugs; however, there may be implications based on the decisions made using this tool.

PIBIS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 1 month and 1 year old.

PIBIS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to hospital discharge, up to one month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to hospital discharge, up to one month

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to hospital discharge, up to one month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Eligibility confirmation

Proportion of children with PIBIS calculation and recommendations

Secondary outcome measures

Proportion of all children with each PIBIS score who are ultimately diagnosed with physical abuse by the CHP Child Protection Team

Proportion of children who undergo neuroimaging (head CT or brain MRI) during the control and intervention periods

Proportion of neuroimaging which demonstrates an abnormality during the control and intervention periods

+1 more

PIBIS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment1 Intervention

Completion of nurse powerform, data collection and physician alert/powerform with score calculation and recommendations.

Group II: Control ArmActive Control1 Intervention

Completion of nurse powerform and data collection only.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,719 Previous Clinical Trials

16,341,732 Total Patients Enrolled

The Beckwith InstituteUNKNOWN

1 Previous Clinical Trials

7 Total Patients Enrolled

Rachel Berger, MDPrincipal InvestigatorUniversity of Pittsburgh

1 Previous Clinical Trials

351 Total Patients Enrolled

Media Library

PIBIS clinical decision support Clinical Trial Eligibility Overview. Trial Name: NCT05034718 — N/A

Traumatic Brain Injury Research Study Groups: Control Arm, Intervention Arm

Traumatic Brain Injury Clinical Trial 2023: PIBIS clinical decision support Highlights & Side Effects. Trial Name: NCT05034718 — N/A

PIBIS clinical decision support 2023 Treatment Timeline for Medical Study. Trial Name: NCT05034718 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research embrace participants of advanced age?

"The current clinical trial is intended for patients between 1 month and 12 months of age. Additionally, there are 167 trials that cater to people younger than 18 years old and 707 studies designed for those over the retirement age."

Answered by AI

What outcome is the research team hoping to attain with this clinical trial?

"The principal outcome of this research, which will be measured over a period lasting up to 1 month from enrolment and hospital discharge, is the confirmation of eligibility. Secondary outcomes include the proportion of all children with each PIBIS score that are ultimately diagnosed with physical abuse by the CHP Child Protection Team; the ratio of eligible children who undergo neuroimaging (head CT or brain MRI) during both control and intervention periods; and finally, how many enrolled participants return to the ED within 6 months for subsequent imaging scans."

Answered by AI

To whom is entry into this experiment open?

"This research trial is seeking 609 infants aged between 30 days and 364 days with clinical decision support. Additionally, the prospective participants must meet the age bracket of 30 days to less than 1 year as well as an Acuity level/ESI score ranging from 3-5."

Answered by AI

Are individuals with certain conditions eligible to participate in this research?

"Sadly, this medical experiment has concluded its recruitment process as per the clinicaltrials.gov website; it was originally posted on July 5th 2021 and last modified on July 12th 2022. However, there are still 913 other studies actively seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Implementation of the Pittsburgh Infant Brain Injury Score

Rachel Berger MD, MPH 2021. "Implementation of the Pittsburgh Infant Brain Injury Score". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05034718.

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