Using botulinum toxin injections to prevent shoulder deformity in babies with a specific nerve injury
Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
PHASE3 · University Hospital, Brest · NCT03198702
This study is testing if botulinum toxin injections can help prevent shoulder problems in babies with a specific nerve injury.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 10 Months to 11 Months |
| Sex | All |
| Sponsor | University Hospital, Brest (other) |
| Locations | 7 sites (Brest and 6 other locations) |
| Trial ID | NCT03198702 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of early intramuscular injections of botulinum toxin type A in babies with obstetrical brachial plexus palsy (OBPP) to prevent shoulder deformities. The study focuses on infants aged 10 to 11 months who exhibit risk factors for shoulder joint issues. Participants will be compared to a sham group to assess the impact of the treatment on shoulder motion and deformity progression. The primary outcome will be measured by the degree of posterior subluxation of the glenohumeral joint at 11 and 18 months of age.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 10 to 11 months with unilateral OBPP and specific risk factors for shoulder deformity.
Not a fit: Patients with bilateral OBPP or those requiring planned surgeries that may interfere with the study will not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of shoulder deformities in infants with OBPP, improving their quality of life and functional outcomes.
How similar studies have performed: Previous uncontrolled studies have suggested that botulinum toxin injections may be effective in preventing shoulder deformities in similar patient populations, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brest and 6 other locations
- CHRU Brest — Brest, France (RECRUITING)
- Institut Régionnal de Réadaptation Centre de Réadaptation pour enfant — Flavigny-sur-Moselle, France (NOT_YET_RECRUITING)
- ESEAN (Etablissement de Santé pour Enfants et Adolescents de la région Nantaise) — Nantes, France (NOT_YET_RECRUITING)
- CHU Nîmes — Nîmes, France (RECRUITING)
- CHU Rennes — Rennes, France (RECRUITING)
- CHU St Etienne — Saint-Etienne, France (NOT_YET_RECRUITING)
- Hôpital national de saint maurice — Saint-Maurice, France (RECRUITING)
Study contacts
- Study coordinator: Sylvain Brochard, Pr
- Email: sylvain.brochard@chu-brest.fr
- Phone: (+33) 02 98 22.33.73
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obstetrical Brachial Plexus Palsy, physiotherapy, children, shoulder deformation, obstetrical brachial plexus palsy