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Can a Play-Based coaching program help preterm babies thrive at home?

NCT ID NCT07820462

Symptom relief Sponsor: University of Minnesota Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Very preterm infants often leave the neonatal intensive care unit with developmental needs that continue at home. This study tests whether a program called SPEEDI can be delivered to families in the first weeks after NICU discharge. Parents learn to read their baby's behavioral cues and stress signs, build confidence, and use developmentally appropriate play to support the parent-infant bond. Researchers compare SPEEDI delivered in the home, SPEEDI delivered by telehealth, and a control group, and they ask families and providers about what helped or got in the way.

What this could mean

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

Active substance
SPEEDI, an early developmental play intervention that coaches parents to read their preterm infant's cues and build the parent-infant relationship
What this could lead to
If it works, this could give families a practical, low-cost way to support a very preterm baby's development during the vulnerable weeks after leaving the NICU.
What could go wrong
This is a small feasibility study of 40 families, so it is designed to test whether the program can be delivered, not whether it improves outcomes. The results may not hold in larger or more diverse groups, and some families may find the sessions hard to attend.

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 40 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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 6 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: * Written informed consent obtained from participant and ability for participant to comply with study requirements * Stated willingness to comply with all study procedures, including consenting parent attendance at all study assessment and intervention visits * Stated willingness to comply with assignment to the homebased, telehealth, or control group * Infant gestational age of less than 32 weeks at birth * Infant hospitalized for more than 28 days following preterm birth * Infant discharged from the NICU between 35 and 44 weeks postmenstrual age * Consenting parent plans to live in Minnesota for a minimum of 6 months from recruitment * Consenting parent must be able to understand and speak English * Consenting parent age 18 years or older Exclusion Criteria: * Infant has a genetic syndrome or metabolic disorder known to be progressive or to have developmental consequences * Infant has a condition that is not compatible with life * Prisoners with infants in the NICU * Pregnant women/persons * Fetuses * Neonates * Non-English speakers * Employees of the researcher * Students of the researcher

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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.

Infant development Neonatal intensive care unit Preterm birth Very preterm infant

How to take part

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

  1. The places running it

    2 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

  • Masonic Institute for the Developing Brain

    Minneapolis, Minnesota, 55414, United States

  • University of Minnesota Masonic Children's Hospital

    Minneapolis, Minnesota, 55454, United States

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