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New app-based program aims to boost brain development in premature babies

NCT ID NCT06688695

Disease control Sponsor: Umeå University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new e-health program for parents of very preterm infants (born before 32 weeks or under 1500 grams). The program provides 18 sessions over two years to help parents support their baby's brain, movement, and language development. Researchers will compare the program to standard care in 176 families to see if it improves child development by age 2.

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 176 people

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

Started

Nov 2024

Expected to finish

Oct 2029

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

0 to 4 months

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: \* Infant born before 32 GV, or with birth weight under 1500 gr. Exclusion Criteria: * Parent(s) younger than 18 ya. * Chromosomal abnormalities, congenital syndromes that may affect the child's development. * Parents unable to understand Swedish. * Parents with severe mental illness or a physical medical condition requiring extensive inpatient care. * Families without a stable living situation, such as parental substance abuse, homelessness, or family living under threat of deportation from Sweden. * Families that have previously participated in the INSPIRE study or the INSPIRE pilot study.

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

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

Premature babies Premature infant

How to take part

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

  1. The places running it

    7 sites. 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

  • Falu County Hospital

    RECRUITING

    Falun, Dalarna County, 791 82, Sweden

  • Karlstad Hospital

    RECRUITING

    Karlstad, Värmland County, 651 85, Sweden

  • Sunderby Hospital

    RECRUITING

    Södra Sunderbyn, Norrbotten County, 954 42, Sweden

  • Sundsvall Hospital

    RECRUITING

    Sundsvall, Västernorrland County, 856 43, Sweden

  • Umeå university hospital

    RECRUITING

    Umeå, Västerbotten County, 90185, Sweden

  • Örebro University Hospital

    RECRUITING

    Örebro, Örebro County, 701 15, Sweden

  • Östersund Hospital

    RECRUITING

    Östersund, Jämtland Härjedalen, 831 83, Sweden

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