Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
POPB-TOX
1 other identifier
interventional
62
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2018
Longer than P75 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2017
CompletedFirst Posted
Study publicly available on registry
June 26, 2017
CompletedStudy Start
First participant enrolled
May 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
March 20, 2026
March 1, 2026
9 years
June 14, 2017
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
compare the effectiveness of BTI with Sham procedure in preventing an increase in glenoid retroversion and three-dimensional deformity
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
At 18 month age
confirm good clinical tolerance of BTI treatment
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
At 18 month age
determine if the treatment changes the frequency and type of surgical interventions in the long term
every years on 2 years old to 10 years old
Study Arms (2)
Toxin group
EXPERIMENTALThe babies receive a botulinum toxin type A injection at the age of 12 months
Sham group
SHAM COMPARATORThe babies receive a simulated injection procedure at the age of 12 months
Interventions
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.
The injection is mimed, the procedure is the same as the botulinum toxin injection.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
CHRU Brest
Brest, 29609, France
Institut Régionnal de Réadaptation Centre de Réadaptation pour enfant
Flavigny-sur-Moselle, 54630, France
ESEAN (Etablissement de Santé pour Enfants et Adolescents de la région Nantaise)
Nantes, France
CHU Nîmes
Nîmes, 30029, France
CHU Rennes
Rennes, 35033, France
CHU St Etienne
Saint-Etienne, 42055, France
Hôpital national de saint maurice
Saint-Maurice, 94410, France
Related Publications (1)
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.
PMID: 31575585DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2017
First Posted
June 26, 2017
Study Start
May 17, 2018
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share