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Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
Sponsor: University Hospital, Brest
Summary
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.
Key Details
Gender
All
Age Range
10 Months - 11 Months
Study Type
INTERVENTIONAL
Enrollment
62
Start Date
2018-05-17
Completion Date
2027-06
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
Botulinum toxin type A injection
A total of 8UI/kg will be injected in the internal shoulder rotator muscles: 2UI/kg in the sub scapular muscle, 3UI/kg in the pectoralis major muscle and 3UI/kg in the teres major/latissimus dorsi muscle.
Sham
The injection is mimed, the procedure is the same as the botulinum toxin injection.
Locations (7)
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