🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy

RecruitingPhase 3Ages 10 Months - 11 MonthsAllUniversity Hospital, Brest
NCT03198702 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

In children population with obstetrical brachial plexus palsy (OBPP), shoulder musculoskeletal deformity is the main cause of morbidity, with a loss of range of shoulder motion, pain and a reduction in social participation. Some uncontrolled studies shows that early injections of botulinum toxin (BTI) in the internal shoulder rotator muscles (which cause the deformity) are one of the most promising treatment for the prevention of bony deformity. The main objective of this study will be the evaluation of the effectiveness of BTI in the internal shoulder rotator muscles at the age of 12 months in preventing an increase in posterior subluxation of the glenohumeral joint in babies with OBPP (evaluated at the ages of 11 months and 18 months), compared to the Sham group.

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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
💊

What it tests

  • Botulinum toxin type A injection
  • Sham
📍

Where

7 sites
CHRU Brest
Brest, France
Institut Régionnal de Réadaptation Centre de Réadaptation pour enfant
Flavigny-sur-Moselle, France
ESEAN (Etablissement de Santé pour Enfants et Adolescents de la région Nantaise)
Nantes, France
CHU Nîmes
Nîmes, France
CHU Rennes
Rennes, France
CHU St Etienne
Saint-Etienne, France
Hôpital national de saint maurice
Saint-Maurice, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy