Intraventricular HemorrhageTherapy BRIDGENCT06256939
Therapy BRIDGE (Bringing Real-Time Instruction Via Developmental and Gestationally-appropriate Education/Coaching) Program: A Pilot Study
A study testing Therapy BRIDGE Program in people with Intraventricular Hemorrhage, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intraventricular Hemorrhage
- What is being tested?
- Therapy BRIDGE Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A diagnosis of IVH, regardless of age at time of enrollment
- Admission to the Cincinnati Children's Hospital NICU
- Must be at least 18 years of age
- Can provide written consent
- Able to participate in the sessions and data collection process
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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:
- 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
- Pilot test the feasibility, acceptability, and efficacy of this program for infants with intraventricular hemorrhage (IVH) and their caregivers.
Read the 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.
- Conditions
- Intraventricular Hemorrhage
- Being tested
- Therapy BRIDGE Program
- Keywords
- IVH, NICU, caregiver education, occupational therapy, physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy BRIDGE ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Therapy BRIDGE Program |
| Control Group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At enrollment and through study completion, an average of 2 months
Secondary outcomes (2)
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).
Measured: 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).
Measured: To be completed at study completion, an average of 2 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start16 Nov 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraventricular HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace Sagester, Children's Hospital Medical Center, Cincinnati
- Investigators
- Grace Sagester, OTD, OTR/L, BCP, Principal investigator, Children's Hospital Medical Center, CincinnatiAshley Pinger, PT, DPT, PCS, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256939
- Sponsor's protocol ID
- 2023-0236
- Acronym
- Therapy BRIDGE
- Status last verified
- Feb 2025
- First submitted
- 4 Jan 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy BRIDGE (Bringing Real-Time Instruction Via Developmental and Gestationally-appropriate Education/Coaching) Program: A Pilot Study
- ClinicalTrials.gov ID
- NCT06256939
- Acronym / sponsor ID
- Therapy BRIDGE / 2023-0236
- Conditions
- Intraventricular Hemorrhage
- Keywords
- IVH, NICU, caregiver education, occupational therapy, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Therapy BRIDGE ProgramThe 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. |
| Control Group | No 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- A diagnosis of IVH, regardless of age at time of enrollment
- Admission to the Cincinnati Children's Hospital NICU
- Must be at least 18 years of age
- Can provide written consent
- Able to participate in the sessions and data collection process
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapy BRIDGE ProgramA 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. | Other | Intervention Group |
Primary outcome
Canadian Occupational Performance Measure (COPM)
Time frame: 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).
2 secondary outcomes
Caregiver Questionnaire of Perceived Feasibility & Acceptability of Therapy BRIDGE Program
Time frame: At enrollment and through study completion, an average of 2 months
Therapist Questionnaire of Acceptability of Therapy BRIDGE Program
Time frame: To be completed at study completion, an average of 2 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Intraventricular Hemorrhage
RecruitingObservational study
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Enrolling by invitationObservational study
Intelligent Physiological Monitoring to Predict Preterm Brain Injury
Cerebral Palsy (CP), Intraventricular Hemorrhage Neonatal
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Active, not recruiting
aSAH Treatment Based on Intraventricular ICP Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial
Aneurysmal Subarachnoid Hemorrhage, Intacranial Hypertension
Not yet recruiting
Intranasal Fresh Mother's Own Milk to Prevent Intraventricular Hemorrhage in Extremely Preterm Infants
Intraventricular Hemorrhage, Premature Birth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Sagester, OTD, OTR/L, BCP principal investigator
Children's Hospital Medical Center, Cincinnati
Ashley Pinger, PT, DPT, PCS principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy BRIDGE Program in people with Intraventricular Hemorrhage, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (COPM) (time frame: At enrollment and through study completion, an average of 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.