NCT03198702

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 10 Months – 11 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Obstetrical Brachial Plexus Palsy

Interventions

Type	Name	Description
DRUG	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.
OTHER	Sham	The injection is mimed, the procedure is the same as the botulinum toxin injection.

Timeline

• Start date: 2018-05-17
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2017-06-26
• Last updated: 2026-03-20

Locations

7 sites across 1 country: France