Plain-English translation of NCT03198702 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial is testing whether botulinum toxin type A injections given at 12 months of age can prevent shoulder deformity in babies born with obstetrical brachial plexus palsy, a nerve injury that affects arm movement. The medication works by relaxing the muscles that pull the shoulder inward, which helps prevent long-term damage to the shoulder joint. Half of the babies will receive the real injection, and half will receive a simulated procedure so researchers can fairly measure how well this treatment works.
Babies born with this nerve injury often develop shoulder problems as they grow, including pain, limited movement, and difficulty with everyday activities. Early studies suggest this medication may prevent these problems from developing, but doctors need to confirm whether it truly works and is safe.
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Your baby will visit the study center at around 12 months old for an injection procedure—either the real treatment or a simulated injection. You'll return for follow-up visits at 18 months and 11 months after the injection so doctors can check your baby's shoulder movement and take imaging scans to see if the treatment prevented deformity. The study lasts about 6 months from the injection visit.
AI-generated summary from trial data · Jun 4, 2026 · Not medical advice
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