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Botulinum Toxin to Prevent Shoulder Deformity in Babies With OBPP
NCT03198702Phase 3
Key facts
- Status
- Recruiting
- Start
- May 2018
- Primary completion
- Jun 2027
- Countries
- 1
- Sponsor
- Centre Hospitalier Universitaire de Brest
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- Obstetrical brachial plexus palsy (OBPI)
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Overview
Phase 3, randomised trial of botulinum toxin type A in Obstetrical brachial plexus palsy (OBPI) (2 arms), sponsored by Centre Hospitalier Universitaire de Brest. Primary endpoint: Change in the percentage posterior migration of the humeral head. Started May 2018; status: recruiting.
02
Design
2 arms- Study design
- Randomized
Toxin group
Botulinum toxin type A injection at 12 months of age
Sham group
Simulated injection procedure at 12 months of age
03
Who it enrols
Babies aged 10-11 months with unilateral OBPP and risk factors for posterior subluxation of the humeral head, excluding those with bilateral OBPP or planned surgery.
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Endpoints
Primary
Change in the percentage posterior migration of the humeral head
Secondary
Increase in glenoid retroversion and three-dimensional deformity
Active and passive joint range of motion and upper limb function
Clinical tolerance of BTI treatment
Trophicity, fibrosis and fatty infiltration of the injected muscles and muscle balance
Frequency and type of surgical interventions
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