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

Intraventricular Hemorrhage Clinical Trial

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

Clinical Trial Summary

The goal of this pilot study is to develop a novel caregiver education and coaching intervention for infants with intraventricular hemorrhage (IVH) and their caregivers during the NICU to home transition. The main questions it aims to answer are: 1. Development of a novel caregiver education and coaching intervention focused on infant development and caregiver needs to "bridge the gap" during the NICU to home transition 2. Pilot test the feasibility, acceptability, and efficacy of this program for infants with intraventricular hemorrhage (IVH) and their caregivers.

Clinical Trial Description

Infants born preterm are often medically complex and at high-risk for neurodevelopmental challenges. During their Neonatal Intensive Care Unit (NICU) stay, infants and caregivers receive continuous support and have constant access to a variety of specialists. Research has shown that caregiver involvement in their infant's care in the NICU helps to improve outcomes. However, caring for these infants upon discharge can be overwhelming to caregivers. Currently, there is no formal intervention in place to support caregivers as they transition their infant home. The overall objectives of the Therapy BRIDGE program are to (1) create a novel caregiver education and coaching intervention focused on infant development and caregiver needs to "bridge the gap" during the NICU to home transition and (2) pilot test the feasibility, acceptability, and efficacy of this program for infants with intraventricular hemorrhage (IVH) and their caregivers. A standardized education and coaching intervention will be developed to promote optimal neurodevelopmental outcomes through caregiver empowerment. This pilot study will enroll up to 15 infants with IVH and their caregivers during their NICU stay. These infant-caregiver dyads will receive up to 10 sessions utilizing the Therapy BRIDGE program over a four-month period that spans the hospital to home transition. Feasibility and acceptability will be measured with caregiver and therapist questionnaires using a 5-point Likert Scale. Intervention efficacy will be measured by administering the Canadian Occupational Performance Measure (COPM) before and after completion of the program and evaluating change scores. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06256939
Study type Interventional
Source Children's Hospital Medical Center, Cincinnati
Contact Grace M Sagester, OTD, OTR/L, BCP
Phone 513-803-4749
Email grace.sagester@cchmc.org
Status Recruiting
Phase N/A
Start date November 16, 2023
Completion date July 2024
View Details
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