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Can early speech therapy boost language in preterm babies?

NCT ID NCT04384328

Disease control Sponsor: Centre Hospitalier Sud Francilien Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 tested an early speech therapy program for children born very prematurely or with severe growth restriction. The program involved 10 to 20 sessions with a trained speech therapist from 6 to 24 months of age. The goal was to see if it could reduce language and communication problems at age 2. The study was terminated early and included 76 participants.

What this could mean

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

Active substance
Early support programme in speech therapy (10-20 sessions from 6 to 24 months corrected age)
What this could lead to
If successful, this program could help reduce language and communication delays in children born very prematurely or with severe growth restriction.
What could go wrong
The study was terminated early and was small (76 participants), non-randomized, and open-label, so results may be limited and not generalizable.

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

76 people

The number who actually took part.

Started

Nov 2019

Finished

Dec 2022

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: * Premature birth \< 32 weeks of amenorrhea * or premature birth with intrauterine growth restriction (IUGR) \< P3 * corrected age ≤ 6 months at the time of inclusion * affiliation to a social security system + mutual insurance Exclusion Criteria: * genetic pathology * ongoing developmental care: psychomotricity or speech therapy * neuromuscular pathology affecting oral and facial motor skills * severe oral disorders: feeding by gastric tube or gastrostomy * severe sensory, auditory or visual impairment * neither of the 2 French-speaking parents

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Conditions

The condition(s) this trial relates to.

fetal growth restriction Language Development Disorders Premature Birth language disorder prevention target

As listed by the trial registrant

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

Language development disorders Preterm birth

Contacts and locations

Locations

  • Centre Hospitalier Louis Mourier

    Colombes, 92700, France

  • Centre Hospitalier Rives de Seine

    Neuilly-sur-Seine, 92200, France

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91100, France

  • Hôpital Antoine Béclère

    Clamart, 92141, France

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