Clinical trial NCT03198702: Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
Official title: Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Obstetrical Brachial Plexus Palsy
Keywords: physiotherapy
children
shoulder deformation
obstetrical brachial plexus palsy
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 62
Sex: ALL
Minimum age (years): 10
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

Primary outcomes:
measure: 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).
timeFrame: At 18 month age
Secondary outcomes:
measure: compare the effectiveness of BTI with Sham procedure in preventing an increase in glenoid retroversion and three-dimensional deformity
timeFrame: At 18 month age
measure: compare the effectiveness of BTI with Sham procedure in the improvement of active and passive joint range of motion and upper limb function
timeFrame: At 18 month age
measure: confirm good clinical tolerance of BTI treatment
timeFrame: At 18 month age
measure: evaluate the effects of BTI on trophicity, fibrosis and fatty infiltration of the injected muscles as well as muscle balance of the OBPP shoulder
timeFrame: At 18 month age
measure: determine if the treatment changes the frequency and type of surgical interventions in the long term
timeFrame: every years on 2 years old to 10 years old
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
city: Flavigny-sur-Moselle
country: France
facility: Institut Régionnal de Réadaptation Centre de Réadaptation pour enfant
city: Nantes
country: France
facility: ESEAN (Etablissement de Santé pour Enfants et Adolescents de la région Nantaise)
city: Nîmes
country: France
facility: CHU Nîmes
city: Rennes
country: France
facility: CHU Rennes
city: Saint Etienne
country: France
facility: CHU St Etienne
city: Saint-Maurice
country: France
facility: Hôpital national de saint maurice
Study officials:
References:
citation: 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.