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Prematurity ComplicationsBabyBridgeNCT06893003

A Pilot Study Comparing Telehealth and In-Person Therapy Service Delivery Following NICU Discharge

A study testing Baby Bridge in people with Prematurity Complications and NICU Infants, run by University of Southern California at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 6 months
What is being tested?
Baby Bridge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
1 May 2023to 3 Mar 2025
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 Up to 6 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • Chronological age >6 months at time of NICU discharge
  • Non-English speakers
  • Those discharging home to a different state/country

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Children's Hospital of Los Angeles

    Los Angeles, California, 90027

  • University of Southern California

    Los Angeles, California, 90089

Other trials in United States

About this study

Official title: A Pilot Study on Cost and Other Implementation Factors Comparing Telehealth and In-Person Therapy Service Delivery Following NICU Discharge

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.

Read the detailed description

Participants and setting

Participants include 20 high-risk parent-infant dyads hospitalized at CHLA. Enrolled infants and families will be randomized to receive Baby Bridge services either through telehealth or in-person visits. Parent-infant dyads will be enrolled at least 2 days before NICU discharge to enable rapport to be established (between the Baby Bridge therapist and family) through a visit to the NICU when possible and via telephone, text or email messaging when an in-person visit is not possible prior to discharge. This first contact will be attempted to be in-person in the NICU for both the telehealth and in-person groups. Enrolled infants and families will then have a Baby Bridge telehealth or in-person visit scheduled within one week of discharge (depending on their group assignment). Subsequent individual weekly visits will be adapted to in-person or telehealth (varying from assigned group) when needed or deemed appropriate (requested by the family or therapist or when an in-person visit is felt to improve the quality of the therapy session). Weekly Baby Bridge programming will be conducted until other therapy through the state-wide early intervention program commences, as in the infant begins receiving therapy services as recommended. Investigators will also track rates of enrollment, rates and reasons for any cancellations, and completion of the program (defined as being seen until community-based early intervention services commenced). Infants will be withdrawn if they are transferred to another hospital prior to discharge or if they are readmitted to the hospital and additional contact was not possible or feasible.

Sociodemographic and medical data will be collected from the electronic medical record for each dyad enrolled to better understand differences between groups as well as to define sample characteristics. Sociodemographic factors collected will include: infant race, insurance type (public or private), maternal age, number of siblings, home distance from the hospital, and categorization of home residence (urban with <3,000 people per square mile, suburban with between 1,000 and 3,000 people per square mile, or rural with <1,000 people per square mile). Medical factors collected will include: estimated gestational age at birth, the primary condition of the infant (congenital anomaly, preterm birth, or neurological condition not related to preterm birth or congenital anomaly), number of days of endotracheal intubation, number of days of hospitalization, and whether or not the infant was orally feeding at time of hospital discharge.

In-person group assignment For those assigned to the in-person Baby Bridge group, the first visit will be scheduled in the home within one week of NICU discharge, and attempts will be made to see the infant weekly in the home environment for a one-hour therapy session. Scheduled visits will be confirmed with families via text messaging the day before each visit. Visits will be rescheduled to telehealth in the event of therapist illness, parent preference or parent/child illness, or distance or therapist schedule limitations. Changes of visits from in-person to telehealth will be tracked along with their reasoning.

Telehealth group assignment For those assigned to the telehealth Baby Bridge group, a first telehealth visit will be scheduled within one week of discharge, and weekly telehealth visits will be scheduled thereafter. However, parents will be informed that in-person visits are an option when needs arise. Adaptations from a telehealth visit to an in-person visit will be made in the event of therapist clinical judgment due to the medical complexity or feeding/tonal abnormalities of the infant and parent preference or rapport building. Visit adaptations will be tracked along with the reasoning for them.

Implementation outcomes The primary outcome of interest for this study will be cost difference between telehealth and in-person visits of the Baby Bridge program. Investigators also plan to investigate implementation outcomes of adoptability (enrollment rate), feasibility (whether program tenets were followed), adaptations, and acceptability (parent satisfaction).

Being tested
Baby Bridge
Keywords
Baby Bridge, Early intervention, Telehealth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Baby BridgeOther

    The Baby Bridge program is an evidence-based implementation strategy aimed at enhancing early and continuous therapy services following NICU discharge for infants with alterations in neurodevelopment. The Baby Bridge program utilizes an occupational or physical therapist to see the infant and family in the NICU prior to discharge, complete a comprehensive neurodevelopmental and feeding assessment to inform targeted interventions, and provide early therapy services in the home environment within one week of discharge and weekly thereafter, until other community-based services commence. While most of the program occurs after NICU discharge, a hallmark of the Baby Bridge program is that families establish rapport with the therapist while the infant is still in the NICU. The therapist also educates the family on ways to support their infant's development between sessions and offers support and assistance during the transition from hospital to home.

Study groups in NCT06893003
Study groupRoleWhat they receive
Telehealth Baby Bridge modelExperimentalFor those assigned to the telehealth Baby Bridge group, a first telehealth visit will be scheduled within one week of discharge, and weekly telehealth visits will be scheduled thereafter. However, parents will be informed that in-person visits are an option when needs arise. Adaptations from a telehealth visit to an in-person visit will be made in the event of therapist clinical judgment due to the medical complexity or feeding/tonal abnormalities of the infant and parent preference or rapport building. Visit adaptations will be tracked along with the reasoning for them.
Receives: Other: Baby Bridge
In-Person Baby Bridge modelActive comparatorFor those assigned to the in-person Baby Bridge group, the first visit will be scheduled in the home within one week of NICU discharge, and attempts will be made to see the infant weekly in the home environment for a one-hour therapy session. Scheduled visits will be confirmed with families via text messaging the day before each visit. Visits will be rescheduled to telehealth in the event of therapist illness, parent preference or parent/child illness, or distance or therapist schedule limitations. Changes of visits from in-person to telehealth will be tracked along with their reasoning.
Receives: Other: Baby Bridge

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cost of the Baby Bridge program

    For the purposes of this project, we estimated costs associated with each Baby Bridge visit. We did not assess cost across group assignment, due to the allowed adaptations to each visit type. Cost was defined in relation to the organizational cost of providing Baby Bridge visits and included the time that the therapist spent conducting therapy sessions (billable time), administrative time (documentation, communication with families), driving (for in-person visits), and mileage reimbursement.

    Measured: From first Baby Bridge visit to last Baby Bridge visit for each infant (approx 12 weeks but varies significantly between infants)

Secondary outcomes (7)
  1. Adoptability of the Baby Bridge program

    Number of infants referred, approached, and enrolled. Adoption was operationalized to include the total number of infants approached versus enrolled (enrollment rate).

    Measured: From first Baby Bridge visit to last Baby Bridge visit for each infant (approx 12 weeks but varies significantly between infants

  2. Feasibility of the Baby Bridge program - Timing

    We captured timing (if the first visit was conducted within one week of discharge); average time from NICU discharge to first Baby Bridge visit); frequency of visits; rate and reasons for any therapy visit cancellations; the completion rates (percentage of enrolled infants who completed programming); and the timing of transition to community-based therapy. Feasibility was defined a priori as all Baby Bridge visits attempted within the first week, infants seen at least 3 visits per month while in the program, and that 80% would be successfully transitioned to early intervention programming.

    Measured: From first Baby Bridge visit to last Baby Bridge visit for each infant (approx 12 weeks but varies significantly between infants

  3. Feasibility of the Baby Bridge program - Frequency

    Frequency of Baby Bridge visits, as well as rate and reasons for any therapy visit cancellations; the completion rates (percentage of enrolled infants who completed programming); and the timing of transition to community-based therapy. Feasibility was defined a priori as all Baby Bridge visits attempted within the first week, infants seen at least 3 visits per month while in the program, and that 80% would be successfully transitioned to early intervention programming.

    Measured: From first Baby Bridge visit to last Baby Bridge visit for each infant (approx 12 weeks but varies significantly between infants

  4. Feasibility of the Baby Bridge program - Completion rate

    Completion rates (percentage of enrolled infants who completed programming); and the timing of transition to community-based therapy. Feasibility was defined a priori as all Baby Bridge visits attempted within the first week, infants seen at least 3 visits per month while in the program, and that 80% would be successfully transitioned to early intervention programming.

    Measured: From first Baby Bridge visit to last Baby Bridge visit for each infant (approx 12 weeks but varies significantly between infants

  5. Feasibility of the Baby Bridge program - Timing of transition

    Timing of transition to community-based therapy

    Measured: From first Baby Bridge visit to last Baby Bridge visit for each infant (approx 12 weeks but varies significantly between infants

  6. Adaptations to the Baby Bridge program

    Proportion of visits conducted via telehealth in the telehealth group and proportion of visits that occurred in-person in the in-person group. Reasoning for such adaptations was tracked as described above in the telehealth and in-person assignment sections.

    Measured: From first Baby Bridge visit to last Baby Bridge visit for each infant (approx 12 weeks but varies significantly between infants

  7. Acceptability of the Baby Bridge program

    Upon completion of the Baby Bridge program, parents were asked to complete the Baby Bridge Parent Survey to query their perceptions about Baby Bridge programming. Survey questions were loaded into REDCap and administered electronically through a shared link to a REDCap survey. Parent satisfaction was measured based on a sum (possible range of 0-10) of the questions on the survey.

    Measured: From first Baby Bridge visit to last Baby Bridge visit for each infant (approx 12 weeks but varies significantly between infants

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2025
  2. Study start1 May 2023
  3. Primary completion31 Oct 2024
  4. Study completion3 Mar 2025

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06893003
Sponsor's protocol ID
AOTFIR21
Other IDs
AOTFIR21
Acronym
BabyBridge
Status last verified
Mar 2025
First submitted
7 Mar 2025
Last updated
25 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Pilot study; small enough sample that even diagnoses could be considered PHI

Questions about this trial

What is this clinical trial studying?

A study testing Baby Bridge in people with Prematurity Complications and NICU Infants, run by University of Southern California at 2 sites 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 3 inclusion and 3 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 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Cost of the Baby Bridge program (time frame: From first Baby Bridge visit to last Baby Bridge visit for each infant (approx 12 weeks but varies significantly between infants)). 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 25 Mar 2025.

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