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

Obstetrical Brachial Plexus Palsy Clinical Trial

— POPB-TOX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03198702
• Other study ID #: POPB-TOX RB15.050
• Status: Recruiting
• Phase: Phase 3
• Start date: May 17, 2018
• Est. completion date: April 2025

Study information

• Verified date: December 2023
• Source: University Hospital, Brest
• Contact: Sylvain Brochard, Pr
• Phone: (+33) 02 98 22.33.73
• Email: sylvain.brochard[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Months to 11 Months

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Brachial Plexus Palsy
• Obstetrical Brachial Plexus Palsy
• Paralysis

Intervention

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.

Other:
• Sham
The injection is mimed, the procedure is the same as the botulinum toxin injection.

Locations

Country	Name	City	State
France	CHRU Brest	Brest
France	Institut Régionnal de Réadaptation Centre de Réadaptation pour enfant	Flavigny-sur-Moselle
France	ESEAN (Etablissement de Santé pour Enfants et Adolescents de la région Nantaise)	Nantes
France	CHU Nîmes	Nîmes
France	CHU Rennes	Rennes
France	CHU St Etienne	Saint Etienne
France	Hôpital national de saint maurice	Saint-Maurice

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	compare the effectiveness of BTI with Sham procedure in preventing an increase in glenoid retroversion and three-dimensional deformity	With 2D glenoid changes measured on axial MRI and 3D glenoid version and migration of the humeral head measured on MRI	At 18 month age
Secondary	compare the effectiveness of BTI with Sham procedure in the improvement of active and passive joint range of motion and upper limb function	By measurement of passive range of motion, Active Movement Scale and Assistive Hand Assessment.	At 18 month age
Secondary	confirm good clinical tolerance of BTI treatment	By measurement of the number of serious and non-serious adverse events	At 18 month age
Secondary	evaluate the effects of BTI on trophicity, fibrosis and fatty infiltration of the injected muscles as well as muscle balance of the OBPP shoulder	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)	At 18 month age
Secondary	determine if the treatment changes the frequency and type of surgical interventions in the long term	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).	every years on 2 years old to 10 years old