NCT03198702 Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
| NCT ID | NCT03198702 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Brest |
| Condition | Obstetrical Brachial Plexus Palsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2018-05-17 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 62 participants in total. It began in 2018-05-17 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03198702 clinical trial?
This trial is open to participants of all sexes, aged 10 Months or older, up to 11 Months, studying Obstetrical Brachial Plexus Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03198702 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 62 participants.
Is NCT03198702 currently recruiting?
Yes, NCT03198702 is actively recruiting participants. Contact the research team at sylvain.brochard@chu-brest.fr for enrollment information.
Where is the NCT03198702 trial being conducted?
This trial is being conducted at Brest, France, Flavigny-sur-Moselle, France, Nantes, France, Nîmes, France and 3 additional locations.
Who is sponsoring the NCT03198702 clinical trial?
NCT03198702 is sponsored by University Hospital, Brest. The trial plans to enroll 62 participants.
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