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

What this Trial Is About

This trial focuses on babies with obstetrical brachial plexus palsy OBPP, a condition causing shoulder muscle deformity that leads to reduced shoulder movement, pain, and social participation difficulties. Researchers are studying whether early injections of botulinum toxin type A BTI into the shoulder muscles at 12 months of age can prevent worsening shoulder deformities compared to a simulated sham procedure. The study is designed as a randomized, double-blind clinical trial sponsored by University Hospital, Brest. Participants are randomly assigned to receive either the botulinum toxin injection or a sham injection at 12 months old. The botulinum toxin dose is 8 UIkg, divided among specific shoulder muscles. The sham group undergoes a simulated injection mimicking the procedure without the active drug. The study measures effects at 11 months before injection and at 18 months six months after injection, with long-term follow-up until 10 years old to assess surgical intervention frequency. Throughout the study, babies will undergo MRI scans to measure shoulder joint positioning and assess muscle condition. Researchers will also evaluate shoulder movement range, upper limb function, and treatment tolerance. The primary outcome is the change in shoulder joint position between 11 and 18 months. Secondary outcomes include muscle condition, joint deformity, and the need for surgery over time. Participation involves clinical assessments and imaging at specific ages, with safety and effectiveness monitored closely.

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