Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy (POPB-TOX)
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|ClinicalTrials.gov Identifier: NCT03198702|
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : October 1, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Obstetrical Brachial Plexus Palsy||Drug: Botulinum toxin type A injection Other: Sham||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
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.
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy|
|Actual Study Start Date :||May 17, 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: Toxin group
The babies receive a botulinum toxin type A injection at the age of 12 months
Drug: Botulinum toxin type A injection
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.
Sham Comparator: Sham group
The babies receive a simulated injection procedure at the age of 12 months
The injection is mimed, the procedure is the same as the botulinum toxin injection.
- 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). [ Time Frame: At 18 month age ]
- compare the effectiveness of BTI with Sham procedure in preventing an increase in glenoid retroversion and three-dimensional deformity [ Time Frame: At 18 month age ]With 2D glenoid changes measured on axial MRI and 3D glenoid version and migration of the humeral head measured on MRI
- compare the effectiveness of BTI with Sham procedure in the improvement of active and passive joint range of motion and upper limb function [ Time Frame: At 18 month age ]By measurement of passive range of motion, Active Movement Scale and Assistive Hand Assessment.
- confirm good clinical tolerance of BTI treatment [ Time Frame: At 18 month age ]By measurement of the number of serious and non-serious adverse events
- evaluate the effects of BTI on trophicity, fibrosis and fatty infiltration of the injected muscles as well as muscle balance of the OBPP shoulder [ Time Frame: At 18 month age ]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)
- determine if the treatment changes the frequency and type of surgical interventions in the long term [ Time Frame: every years on 2 years old to 10 years old ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198702
|Contact: Sylvain Brochard, Pr||(+33) 02 98 email@example.com|
|Brest, France, 29609|
|Contact: Sylvain BROCHARD, Pr 02 98 22 33 73|
|Contact: Chritelle PONS, Dr 02 98 22 33 73|
|Principal Investigator: Sylvain BROCHARD, Pr|
|Sub-Investigator: Christelle PONS, Dr|
|Institut Régionnal de Réadaptation Centre de Réadaptation pour enfant||Not yet recruiting|
|Flavigny-sur-Moselle, France, 54630|
|Contact: Emilie RUMILLY, Dr 03 83 85 85 85|
|Contact: Jennifer BASTIEN, Dr|
|Principal Investigator: Emilie RUMILLY, Dr|
|Sub-Investigator: Jennifer BASTIEN, Dr|
|CHU Nîmes||Not yet recruiting|
|Nîmes, France, 30029|
|Contact: Mélanie PORTE, Dr 04 66 68 68 68|
|Principal Investigator: Mélanie PORTE, Dr|
|CHU Rennes||Not yet recruiting|
|Rennes, France, 35033|
|Contact: Philippe VIOLAS, Dr 02 99 28 43 21|
|Principal Investigator: Philippe VIOLAS, Dr|
|Sub-Investigator: Helene RAUSCENT, Dr|
|Sub-Investigator: Floriane COLIN, Dr|
|CHU St Etienne||Not yet recruiting|
|Saint Etienne, France, 42055|
|Contact: Madeleine ASLAN, Dr 04 77 82 80 37 firstname.lastname@example.org|
|Contact: Vincent GAUTHERON, Pr 04 77 82 80 00 email@example.com|
|Sub-Investigator: Vincent GAUTHERON, Pr|
|Principal Investigator: Madeleine ASLAN, Dr|
|Sub-Investigator: Bruno DOHIN, Pr|
|Hôpital national de saint maurice||Recruiting|
|Saint-Maurice, France, 94410|
|Contact: Nathaly QUINTERO, Dr 01 43 96 63 50 firstname.lastname@example.org|
|Contact: Anne-Gaëlle PY, Dr email@example.com|
|Principal Investigator: Nathaly QUINTERO, Dr|
|Sub-Investigator: Anne-Gaëlle PYDr, Dr|
|Sub-Investigator: Katherine SANCHEZ, Dr|