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Botox shots may save Babies' shoulders from lifelong deformity

NCT ID NCT03198702

Disease control Sponsor: University Hospital, Brest Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 giving botulinum toxin (Botox) injections early can prevent shoulder bone deformities in babies with obstetrical brachial plexus palsy, a nerve injury at birth. About 62 babies aged 10-11 months will receive either the injection or a sham procedure. The goal is to see if the treatment keeps the shoulder joint properly aligned and reduces long-term pain and movement problems.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 62 people

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

Started

May 2018

Expected to finish

Jun 2027

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

10 to 11 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: * Male and female babies with unilateral OBPP * Age between 10 and 11 months * Presenting one of 2 risk factors for posterior subluxation of the humeral head (10° less passive external ROM of the affected shoulder compared with the contralateral shoulder and/or a score strictly less than 6 on the AMS for shoulder external rotation and abduction, elbow flexion or supination) * Signature of the consent form by (the) parent(s) over the age of majority Exclusion Criteria: * Bilateral OBPP * Microsurgery or secondary muscle surgery planned between 12 and 18 months of age * Contraindications to the use of botulinum toxin * Contraindications to MRI * MRI not possible in the Paediatric Day Hospital setting because of contraindications to the sedation protocol or due to organisational constraints * Parents inapt to provide consent for the participation of their child * Parents under the age of 18 years

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Conditions

The condition(s) this trial relates to.

Erb palsy Neonatal Brachial Plexus Palsy non-recovering obstetric brachial plexus lesion

As listed by the trial registrant

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

Obstetrical brachial plexus palsy

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

  • CHRU Brest

    RECRUITING

    Brest, 29609, France

  • CHU Nîmes

    RECRUITING

    Nîmes, 30029, France

  • CHU Rennes

    RECRUITING

    Rennes, 35033, France

  • CHU St Etienne

    NOT_YET_RECRUITING

    Saint-Etienne, 42055, France

  • ESEAN (Etablissement de Santé pour Enfants et Adolescents de la région Nantaise)

    NOT_YET_RECRUITING

    Nantes, France

  • Hôpital national de saint maurice

    RECRUITING

    Saint-Maurice, 94410, France

  • Institut Régionnal de Réadaptation Centre de Réadaptation pour enfant

    NOT_YET_RECRUITING

    Flavigny-sur-Moselle, 54630, France

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