A Pilot Study Comparing Telehealth and In-Person Therapy Service Delivery Following NICU Discharge (NCT06893003) | Clinical Trial Compass
CompletedNot Applicable
A Pilot Study Comparing Telehealth and In-Person Therapy Service Delivery Following NICU Discharge
United States20 participantsStarted 2023-05-01
Plain-language summary
20 high-risk parent-infant dyads hospitalized in a 58-bed level IV NICU will be randomized to either receive Telehealth or in-person Baby Bridge services. Baby Bridge is a program to bridge the gap between NICU discharge and initiation of community-based early intervention services. Weekly therapy services are provided in the child's home, either via telehealth or in-person. An in-person evaluation in the NICU is attempted for each child prior to NICU discharge. Cost, adoptability, feasibility, adaptations, and acceptability amongst caregivers will be compared between the two groups.
Who can participate
Age range
6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Hospitalized in the NICU for \>7 days
* Received a referral for early intervention at time of NICU discharge
* Was referred to program at least 48 hours before NICU discharge
Exclusion Criteria:
* Chronological age \>6 months at time of NICU discharge
* Non-English speakers
* Those discharging home to a different state/country
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cost of the Baby Bridge program
Timeframe: From first Baby Bridge visit to last Baby Bridge visit for each infant (approx 12 weeks but varies significantly between infants)