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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toxin group | Experimental | The babies receive a botulinum toxin type A injection at the age of 12 months |
|
| Sham group | Sham Comparator | The babies receive a simulated injection procedure at the age of 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A injection | Drug | A total of 8UI/kg will be injected in the internal shoulder rotator muscles: 2UI/kg in the sub scapular muscle, 3UI/kg in the pectoralis major muscle and 3UI/kg in the teres major/latissimus dorsi muscle. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the percentage posterior migration of the humeral head measured on axial MRI slices between 11 (before the BTI carried out at 12 months) and 18 months of age (6 months post BTI). | At 18 month age |
| Measure | Description | Time Frame |
|---|---|---|
| compare the effectiveness of BTI with Sham procedure in preventing an increase in glenoid retroversion and three-dimensional deformity | With 2D glenoid changes measured on axial MRI and 3D glenoid version and migration of the humeral head measured on MRI | At 18 month age |
| compare the effectiveness of BTI with Sham procedure in the improvement of active and passive joint range of motion and upper limb function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sylvain Brochard, Pr | Contact | (+33) 02 98 22.33.73 | sylvain.brochard@chu-brest.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Brest | Recruiting | Brest | 29609 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31575585 | Derived | Pons C, Eddi D, Le Gal G, Garetier M, Ben Salem D, Houx L, Fitoussi F, Quintero N, Brochard S; POPB-TOX Group. Effectiveness and safety of early intramuscular botulinum toxin injections to prevent shoulder deformity in babies with brachial plexus birth injury (POPB-TOX), a randomised controlled trial: study protocol. BMJ Open. 2019 Sep 30;9(9):e032901. doi: 10.1136/bmjopen-2019-032901. |
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First group or "toxin" group: the babies will receive BOTOX injections at the age of 12 months in the shoulder muscles.
Second group or "sham" group:the babies receive the same procedure but no injection.
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| Sham | Other | The injection is mimed, the procedure is the same as the botulinum toxin injection. |
|
By measurement of passive range of motion, Active Movement Scale and Assistive Hand Assessment. |
| At 18 month age |
| confirm good clinical tolerance of BTI treatment | By measurement of the number of serious and non-serious adverse events | At 18 month age |
| evaluate the effects of BTI on trophicity, fibrosis and fatty infiltration of the injected muscles as well as muscle balance of the OBPP shoulder | Bu measurement of the degree of trophicity, fibrosis and fatty infiltration of the injected muscles (supraspinous, infraspinous, teres minor, subscapularis, teres major, pectoralis major, deltoid and latissimus dorsi) | At 18 month age |
| determine if the treatment changes the frequency and type of surgical interventions in the long term | the number and type of surgical interventions undergone by the children in each group will be recorded during routine medical follow-up (as in usual practice) until the child's 10th birthday following unblinding (9 years and 6 months after the BTI). | every years on 2 years old to 10 years old |
| Institut Régionnal de Réadaptation Centre de Réadaptation pour enfant | Not yet recruiting | Flavigny-sur-Moselle | 54630 | France |
|
| ESEAN (Etablissement de Santé pour Enfants et Adolescents de la région Nantaise) | Not yet recruiting | Nantes | France |
|
| CHU Nîmes | Recruiting | Nîmes | 30029 | France |
|
| CHU Rennes | Recruiting | Rennes | 35033 | France |
|
| CHU St Etienne | Not yet recruiting | Saint-Etienne | 42055 | France |
|
| Hôpital national de saint maurice | Recruiting | Saint-Maurice | 94410 | France |
|
| ID | Term |
|---|---|
| D000076984 | Neonatal Brachial Plexus Palsy |
| ID | Term |
|---|---|
| D020516 | Brachial Plexus Neuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D001720 | Birth Injuries |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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