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Behavioural Intervention

Intervention Group for Intraventricular Hemorrhage (Therapy BRIDGE Trial)

N/A

Recruiting

Led By Grace Sagester, OTD, OTR/L, BCP

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

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

Must have

Infant participants: A diagnosis of IVH, regardless of age at time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at enrollment and through study completion, an average of 2 months

Awards & highlights

Therapy BRIDGE Trial Summary

This trial aims to create a new program to help caregivers of infants with intraventricular hemorrhage (IVH) during the transition from the NICU to home. The study will focus on educating

Who is the study for?

This trial is for caregivers and their infants who have experienced intraventricular hemorrhage (IVH), a type of brain bleed, during their stay in the Neonatal Intensive Care Unit (NICU). The study focuses on supporting these families as they transition from hospital to home care.Check my eligibility

What is being tested?

The Therapy BRIDGE Program is being tested. It's an educational and coaching intervention designed to help caregivers understand infant development and address their own needs while moving from NICU to home care with an IVH-affected infant.See study design

What are the potential side effects?

Since this program involves education and coaching rather than medical or pharmaceutical interventions, traditional side effects are not applicable. However, there may be emotional or psychological impacts from participating in such a program.

Therapy BRIDGE Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My infant has been diagnosed with IVH.

Therapy BRIDGE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at enrollment and through study completion, an average of 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at enrollment and through study completion, an average of 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at enrollment and through study completion, an average of 2 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Canadian Occupational Performance Measure (COPM)

Secondary outcome measures

Caregiver Questionnaire of Perceived Feasibility & Acceptability of Therapy BRIDGE Program

Therapist Questionnaire of Acceptability of Therapy BRIDGE Program

Therapy BRIDGE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

The Therapy BRIDGE program is a prospective, longitudinal, non-randomized pilot study for infants diagnosed with IVH and their caregivers. The Therapy BRIDGE program will begin as the infant is nearing discharge from the NICU and continue as the infant transitions to home. It will use a hybrid model including both in-person and telehealth sessions.

Group II: Control GroupActive Control1 Intervention

In the instance that a patient is deemed eligible to participate in the Therapy BRIDGE program and the caregiver chooses not to participate, the caregiver will be offered the opportunity to be enrolled in the control arm of our study as part of a monitoring group. This group of patients will continue to receive usual care while admitted to the NICU and any outpatient recommendations will be deferred to the primary NICU therapists caring for the infant based on the patient's individualized needs.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,576 Total Patients Enrolled

Grace Sagester, OTD, OTR/L, BCPPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

Ashley Pinger, PT, DPT, PCSPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

Frequently Asked Questions

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

Are patients currently able to enroll in this ongoing study?

"Indeed, the details available on clinicaltrials.gov affirm that this study is presently in search of eligible participants. The trial was first listed on November 16th, 2023 and most recently revised on February 5th, 2024. Recruitment aims to enroll a total of 15 individuals from one designated site."

Answered by AI

What is the cumulative enrollment count for participants in this clinical investigation?

"Affirmative. The details on clinicaltrials.gov reveal that this research study is actively seeking participants. Originally shared on November 16th, 2023, the trial underwent its latest revision on February 5th, 2024. There are openings for enrollment of up to 15 individuals at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Therapy BRIDGE (Bringing Real-Time Instruction Via Developmental and Gestationally-appropriate Education/Coaching) Program: A Pilot Study

Grace Sagester 2023. "Therapy BRIDGE (Bringing Real-Time Instruction Via Developmental and Gestationally-appropriate Education/Coaching) Program: A Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06256939.

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