Botulinum toxin type A for Obstetrical brachial plexus palsy

Inclusion criteria

• {"criterion_text":"- Male or female babies with unilateral POPB."}
• {"criterion_text":"- More than 10 months and less than 11 months of age."}
• {"criterion_text":"- Presenting, on the affected side, one of the following 2 risk factors for posterior subluxation of the humeral head: 1/ A limitation of passive joint amplitude in external rotation on the shoulder with respect to the contralateral side of at least 10°. 2/ Active Movement Scale (AMS) score strictly below 6 for external rotation, shoulder abduction, elbow flexion or supination."}
• {"criterion_text":"- With consent of adult parents."}

Exclusion criteria

• {"criterion_text":"- Bilateral POPB"}
• {"criterion_text":"- Microsurgical management or scheduled secondary muscle surgery between 12 and 18 months of age."}
• {"criterion_text":"- Non-inclusion related to botulinum toxin use (hypersensitivity to botulinum toxin or excipients, myasthenia)."}
• {"criterion_text":"- Classic contraindications to MRI: pacemaker, metal implantable devices, ocular foreign bodies, etc."}
• {"criterion_text":"- Impossibility of performing an MRI in a Pediatric Day Hospital, due to contraindications linked to the sedation protocol or organizational constraints."}
• {"criterion_text":"- Parent(s) unable to give informed consent."}
• {"criterion_text":"- Minor parent(s)"}

Primary endpoints

• {"endpoint_text":"- Evolution of the percentage of posterior migration of the humeral head measured in MRI on an axial section, between 11 months (before botulinum toxin injection at 12 months) and 18 months (6 months after injection) of age.","definition_or_measurement_approach":"Measured by MRI on an axial section comparing percentage of posterior migration of the humeral head between 11 months (pre-injection) and 18 months (6 months post-injection)."}

Secondary endpoints

• {"endpoint_text":"- 2D glenoid evolution measured in MRI on an axial slice (1st secondary objective)","definition_or_measurement_approach":"Measured by MRI on an axial slice (2D assessment of glenoid evolution)."}
• {"endpoint_text":"- Evolution of the glenoid version and three-dimensional humeral head migration on MRI (1st secondary objective)","definition_or_measurement_approach":"Measured by MRI assessing glenoid version and 3D humeral head migration."}
• {"endpoint_text":"- Changes in passive joint amplitudes (2nd secondary objective)","definition_or_measurement_approach":"Assessment of passive joint range of motion (amplitudes) over time."}
• {"endpoint_text":"- Evolution of the AMS (Active Movement Scale) (2nd secondary objective)","definition_or_measurement_approach":"Measurement using the Active Movement Scale to evaluate changes in active movement."}
• {"endpoint_text":"- Progression of mini-AHA (mini-Assistive Hand Assessment) score (2nd secondary objective)","definition_or_measurement_approach":"Assessment using the mini-AHA score to evaluate hand function progression."}
• {"endpoint_text":"- Assessment of the number of non-serious and serious adverse events (3rd secondary objective)","definition_or_measurement_approach":"Recording and counting non-serious and serious adverse events during the study period."}
• {"endpoint_text":"- Assessment of trophicity (muscle volume) and fatty infiltration of injected muscles (supraspinatus, infraspinatus and lesser round, subscapularis, greater round, pectoralis major, deltoid, greater dorsalis) (4th secondary objective).","definition_or_measurement_approach":"Assessment (likely by imaging) of muscle volume and fatty infiltration of listed injected muscles."}
• {"endpoint_text":"- Surgical management of the children included in each group will be recorded post-study during medical follow-up (routine clinical practice) up to the 10th year of life after the blind has been lifted (5th secondary objective).","definition_or_measurement_approach":"Collection of data on surgical interventions during routine follow-up up to age 10 after unblinding."}

France

Earliest CTIS Part Ii Submission Date

27-01-2025

Latest Decision Or Authorization Date

28-04-2025

Processing Time Days

91

Number Of Sites

7

Number Of Participants

62

Primary sponsor

Full Name

Centre Hospitalier Regional Et Universitaire De Brest

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France