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Study identifier: NCT03198702 Synced from ClinicalTrials.gov · July 28, 2026
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Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy

Condition: Obstetrical Brachial Plexus Palsy  ·  Sponsor: University Hospital, Brest

PhasePhase 3
Planned participants62
Who can joinAll sexes, 10 Months to 11 Months
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Sylvain Brochard, Pr  ·  (+33) 02 98 22.33.73  ·  sylvain.brochard@chu-brest.fr

Always discuss trial participation with your own doctor first.

Locations (7)

CHRU BrestBrest, FranceRecruiting
Institut Régionnal de Réadaptation Centre de Réadaptation pour enfantFlavigny-sur-Moselle, FranceNot Yet Recruiting
ESEAN (Etablissement de Santé pour Enfants et Adolescents de la région Nantaise)Nantes, FranceNot Yet Recruiting
CHU NîmesNîmes, FranceRecruiting
CHU RennesRennes, FranceRecruiting
CHU St EtienneSaint-Etienne, FranceNot Yet Recruiting
Hôpital national de saint mauriceSaint-Maurice, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT03198702