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ClinicalTrials.gov ID

NCT03198702

Lead Sponsor

University Hospital, BrestOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

62Estimated

Last Update Posted

Mar 20, 2026Actual

Start Date

May 17, 2018Actual

Primary Completion Date

Jun 2027Estimated

Completion Date

Jun 2027Estimated

Official Title

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

Brief 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.

• Obstetrical Brachial Plexus Palsy

• Botulinum toxin type A injection
• Sham

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Male and female babies with unilateral OBPP
• Age between 10 and 11 months
• Presenting one of 2 risk factors for posterior subluxation of the humeral head (10° less passive external ROM of the affected shoulder compared with the contralateral shoulder and/or a score strictly less than 6 on the AMS for shoulder external rotation and abduction, elbow flexion or supination)
• Signature of the consent form by (the) parent(s) over the age of majority

Exclusion Criteria:

• Bilateral OBPP
• Microsurgery or secondary muscle surgery planned between 12 and 18 months of age
• Contraindications to the use of botulinum toxin
• Contraindications to MRI
• MRI not possible in the Paediatric Day Hospital setting because of contraindications to the sedation protocol or due to organisational constraints
• Parents inapt to provide consent for the participation of their child
• Parents under the age of 18 years

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

University Hospital, BrestOTHER

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