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

PHASE3RecruitingINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

May 17, 2018

Primary Completion Date

April 30, 2025

Study Completion Date

April 30, 2025

Conditions
Obstetrical Brachial Plexus Palsy
Interventions
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.

Trial Locations (7)

29609

RECRUITING

CHRU Brest, Brest

30029

RECRUITING

CHU Nîmes, Nîmes

35033

RECRUITING

CHU Rennes, Rennes

42055

NOT_YET_RECRUITING

CHU St Etienne, Saint-Etienne

54630

NOT_YET_RECRUITING

Institut Régionnal de Réadaptation Centre de Réadaptation pour enfant, Flavigny-sur-Moselle

94410

RECRUITING

Hôpital national de saint maurice, Saint-Maurice

Unknown

NOT_YET_RECRUITING

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

All Listed Sponsors
lead

University Hospital, Brest

OTHER