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Can weekly video coaching help preterm babies find their voice?

NCT ID NCT07738224

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Last updated Sep 03, 2026 · Updated 4 times

Summary

This trial tests whether a telehealth program called Babble Boot Camp can improve early communication in babies born very preterm (before 32 weeks). Parents in the treatment group join weekly 15-minute coaching sessions with a speech pathologist for six months, learning activities to weave into daily routines. The study compares their children's language skills and family well-being against a usual-care group, asking whether this proactive approach can support the earliest stages of speech and language.

What this could mean

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

Active substance
Babble Boot Camp, a telehealth parent-coaching speech and language intervention
What this could lead to
If it works, this could offer a practical, home-based way to improve early communication skills in preterm infants and support parents, potentially reducing later language delays.
What could go wrong
The trial is relatively small and early, so results may not apply to all preterm infants. Success depends on parents' consistent participation, and the intervention may not produce lasting language gains.

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 86 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

Aug 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

Up to 6 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: * Infants born \<32 weeks' gestational age (GA) * Infants medically stable and not ventilator dependent at recruitment * Primary language spoken at home is English * Participants able to attend 6 months of telehealth early intervention * Infants less than 5.5 months corrected age Exclusion Criteria: * Diagnosis of a chromosomal or genetic anomaly known to affect development, * Significant hearing and vision loss * Clefting of the lip or palate * Hypoxic ischemic encephalopathy * Intraventricular haemorrhage grade 3 or 4 * Participants participating in any other trials including BBC

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Conditions

The condition(s) this trial relates to.

communication disorder Premature Birth

As listed by the trial registrant

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

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

  • Murdoch Children's Research Institute

    Melbourne, Victoria, Australia

  • The Royal Women's Hospital

    Melbourne, Victoria, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.