Intraventricular Hemorrhage
Conditions
Keywords
IVH, NICU, caregiver education, occupational therapy, physical therapy
Brief 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.
Detailed 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.
Interventions
OTHERTherapy BRIDGE Program
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.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
for infant participants: * A diagnosis of IVH, regardless of age at time of enrollment * Admission to the Cincinnati Children's Hospital NICU Inclusion Criteria for caregiver participants: * Must be at least 18 years of age * Can provide written consent * Able to participate in the sessions and data collection process
Exclusion criteria
for infant and caregiver participants: * Transfer out of the NICU prior to discharge or require tracheostomy with ventilator dependence as they will not be discharged directly from the CCHMC NICU * Infants and caregivers who live outside of the CCHMC service area and will not be eligible for follow up with CCHMC therapies will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Canadian Occupational Performance Measure (COPM) | At enrollment and through study completion, an average of 2 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Questionnaire of Perceived Feasibility & Acceptability of Therapy BRIDGE Program | At enrollment and through study completion, an average of 2 months | 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). |
| Therapist Questionnaire of Acceptability of Therapy BRIDGE Program | To be completed at study completion, an average of 2 months after enrollment | 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). |
Countries
United States
Outcome results
None listed