Clinical trial

Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy

NCT03198702

Name

POPB-TOX RB15.050

Description

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 arms

Trial start

2018-05-17

Estimated PCD

2025-04-01

Trial end

2025-04-01

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Toxin group

Sham

The injection is mimed, the procedure is the same as the botulinum toxin injection.

Arms:

Sham group

Size

Primary endpoint

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

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'First group or "toxin" group: the babies will receive BOTOX injections at the age of 12 months in the shoulder muscles.\n\nSecond group or "sham" group:the babies receive the same procedure but no injection.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 62, 'type': 'ESTIMATED'}}

Updated at

2023-12-14

1 organization

1 product

1 indication

Organization

University Hospital Brest

Product

Botulinum toxin type A

Indication

Obstetrical Brachial Plexus Palsy