An interventional study of Therapy BRIDGE Program in Intraventricular Hemorrhage, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-02-20.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment
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:
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.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 15 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
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Inclusion Criteria for infant participants:
Inclusion Criteria for caregiver participants:
Exclusion Criteria for infant and caregiver participants:
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.
Other: Therapy BRIDGE Program
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.
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.
Canadian Occupational Performance Measure (COPM)
A client-centered outcome measure that helps identify and prioritize barriers that limit participation in meaningful activities (e.g., play, feeding, sleep, etc.). The COPM is a valid, responsive, and reliable scale that allows researchers to determine clinically significant changes in participants' performance and satisfaction. Participants will rate items on a scale of 1-10 with the average performance/satisfaction scores calculated (higher correlates with higher satisfaction/performance).
Time frame: At enrollment and through study completion, an average of 2 months
Caregiver Questionnaire of Perceived Feasibility & Acceptability of Therapy BRIDGE Program
Caregiver questionnaire to measure feasibility and acceptability. Participants will rate items on a scale of 1-5 with the average scores calculated (higher correlates with higher acceptance/performance).
Time frame: At enrollment and through study completion, an average of 2 months
Therapist Questionnaire of Acceptability of Therapy BRIDGE Program
Questionnaire to measure therapist's acceptability of novel education program. Participants will rate items on a scale of 1-5 with the average scores calculated (higher correlates with higher acceptance/performance).
Time frame: To be completed at study completion, an average of 2 months after enrollment
Plan to share: No
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati