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Can a virtual program boost development in kids with brain injuries?

NCT ID NCT06643598

Disease control Sponsor: University of Wisconsin, Madison Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a virtual version of the Abecedarian Approach, an early childhood education program, can help children ages 0-5 who had a brain injury from lack of oxygen (HIE) or were born very prematurely. Researchers will enroll 225 families and measure parent satisfaction and child development over time. The goal is to see if online delivery works as well as in-person programs, especially for families in rural areas.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Abecedarian Approach (behavioral education program delivered virtually)
What this could lead to
If it works, this could provide a scalable, virtual way to support early development in children with brain injuries or premature birth, especially in rural areas.
What could go wrong
This is a relatively small, early-stage behavioral study with no control group comparison yet. Results may not apply to all families, and virtual delivery may be less effective than in-person programs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 225 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 5 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. IPNH-NDCP patients, including: * Term-born children diagnosed during the neonatal period with hypoxic-ischemic encephalopathy, or * premature children (born at less than 28 weeks gestational age). 2. Parent or legal guardian will also be enrolled as a participant 3. Parents must be English-speaking (able to provide consent and complete questionnaires). Exclusion Criteria: 1. Not suitable for study participation due to other reasons at the discretion of the investigator. 2. Infants with chromosomal abnormalities, genetic syndromes (for example, such as Down Syndrome or Trisomy18) and major congenital malformations will be excluded. 3. Infants with vision impairment will also be excluded from the study, as our study procedures do require intact vision to be able to complete. 4. For parents or legal guardians, there are no exclusion criteria.

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia cerebral palsy nervous system disorder perinatal asphyxia Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cerebral palsy Hypoxic ischaemic encephalopathy (HIE) Neurological disorder Premature birth

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Wisconsin Madison

    RECRUITING

    Madison, Wisconsin, 53715, United States

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