Informations générales (source: ClinicalTrials.gov)
Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
Interventional
Phase 3
University Hospital, Brest (Voir sur ClinicalTrials)
mai 2018
juin 2027
02 avril 2026
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| LES HOPITAUX DE SAINT MAURICE | Nathaly QUINTERO, Dr | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU Brest - 29609 - Brest - France | Sylvain BROCHARD, Pr | Contact (sur clinicalTrials) | |||
| CHU Nîmes - 30029 - Nîmes - France | Mélanie PORTE, Dr | Contact (sur clinicalTrials) | |||
| CHU Rennes - 35033 - Rennes - France | Philippe VIOLAS, Dr | Contact (sur clinicalTrials) | |||
| CHU St Etienne - 42055 - Saint-Etienne - France | Madeleine ASLAN, Dr | Contact (sur clinicalTrials) | |||
| ESEAN (Etablissement de Santé pour Enfants et Adolescents de la région Nantaise) - Nantes - France | Guy LETELLIER, Dr | Contact (sur clinicalTrials) | |||
| Institut Régionnal de Réadaptation Centre de Réadaptation pour enfant - 54630 - Flavigny-sur-Moselle - France | Jennifer BASTIEN, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
- 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