Using botulinum toxin injections to prevent shoulder deformity in babies with a specific nerve injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of early intramuscular injections of botulinum toxin type A in babies with obstetrical brachial plexus palsy (OBPP) to prevent shoulder deformities. The study focuses on infants aged 10 to 11 months who exhibit risk factors for shoulder joint issues. Participants will be compared to a sham group to assess the impact of the treatment on shoulder motion and deformity progression. The primary outcome will be measured by the degree of posterior subluxation of the glenohumeral joint at 11 and 18 months of age.

Why it matters

Who can join: the full rules

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

Where it's running

• CHRU Brest
  Brest, France Recruiting
• CHU Nîmes
  Nîmes, France Recruiting
• CHU Rennes
  Rennes, France Recruiting
• Hôpital national de saint maurice
  Saint-Maurice, France Recruiting
• Institut Régionnal de Réadaptation Centre de Réadaptation pour enfant
  Flavigny-sur-Moselle, France Not yet recruiting
• ESEAN (Etablissement de Santé pour Enfants et Adolescents de la région Nantaise)
  Nantes, France Not yet recruiting

Study contacts

• Study coordinator: Sylvain Brochard, Pr
• Email: sylvain.brochard@chu-brest.fr
• Phone: (+33) 02 98 22.33.73

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.