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

Last updated: February 3, 2025
Sponsor: University Hospital, Brest
Overall Status: Active - Recruiting

Phase

3

Condition

Cataplexy

Treatment

Botulinum toxin type A injection

Sham

Clinical Study ID

NCT03198702
POPB-TOX RB15.050
  • Ages 10-11
  • All Genders

Study 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

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 contralateralshoulder and/or a score strictly less than 6 on the AMS for shoulder externalrotation and abduction, elbow flexion or supination)

  • Signature of the consent form by (the) parent(s) over the age of majority

Exclusion

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 contraindicationsto 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

Study Design

Total Participants: 62
Treatment Group(s): 2
Primary Treatment: Botulinum toxin type A injection
Phase: 3
Study Start date:
May 17, 2018
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • CHU Angers

    Angers, 49103
    France

    Site Not Available

  • CHRU Brest

    Brest, 29609
    France

    Active - Recruiting

  • Institut Régionnal de Réadaptation Centre de Réadaptation pour enfant

    Flavigny-sur-Moselle, 54630
    France

    Site Not Available

  • ESEAN (Etablissement de Santé pour Enfants et Adolescents de la région Nantaise)

    Nantes,
    France

    Site Not Available

  • CHU Nîmes

    Nîmes, 30029
    France

    Active - Recruiting

  • CHU Rennes

    Rennes, 35033
    France

    Active - Recruiting

  • CHU St Etienne

    Saint Etienne, 42055
    France

    Site Not Available

  • Hôpital national de saint maurice

    Saint-Maurice, 94410
    France

    Active - Recruiting

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