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

December 13, 2023 updated by: University Hospital, Brest

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Brest, France, 29609
        • Recruiting
        • CHRU Brest
        • Contact:
          • Sylvain BROCHARD, Pr
          • Phone Number: 02 98 22 33 73
        • Contact:
          • Chritelle PONS, Dr
          • Phone Number: 02 98 22 33 73
        • Principal Investigator:
          • Sylvain BROCHARD, Pr
        • Sub-Investigator:
          • Christelle PONS, Dr
      • Flavigny-sur-Moselle, France, 54630
      • Nantes, France
        • Not yet recruiting
        • ESEAN (Etablissement de Santé pour Enfants et Adolescents de la région Nantaise)
        • Contact:
        • Principal Investigator:
          • Guy LETELLIER, Dr
      • Nîmes, France, 30029
        • Recruiting
        • Chu Nimes
        • Contact:
          • Mélanie PORTE, Dr
          • Phone Number: 04 66 68 68 68
        • Principal Investigator:
          • Mélanie PORTE, Dr
      • Rennes, France, 35033
        • Recruiting
        • CHU Rennes
        • Contact:
          • Philippe VIOLAS, Dr
          • Phone Number: 02 99 28 43 21
        • Principal Investigator:
          • Philippe VIOLAS, Dr
        • Sub-Investigator:
          • Helene RAUSCENT, Dr
        • Sub-Investigator:
          • Floriane COLIN, Dr
      • Saint Etienne, France, 42055
        • Not yet recruiting
        • CHU St Etienne
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Vincent GAUTHERON, Pr
        • Principal Investigator:
          • Madeleine ASLAN, Dr
        • Sub-Investigator:
          • Bruno DOHIN, Pr
      • Saint-Maurice, France, 94410
        • Recruiting
        • Hôpital national de saint maurice
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nathaly QUINTERO, Dr
        • Sub-Investigator:
          • Anne-Gaëlle PYDr, Dr
        • Sub-Investigator:
          • Katherine SANCHEZ, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 months (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Toxin group
The babies receive a botulinum toxin type A injection at the age of 12 months
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.
Sham Comparator: Sham group
The babies receive a simulated injection procedure at the age of 12 months
Other: Sham
The injection is mimed, the procedure is the same as the botulinum toxin injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: At 18 month age
At 18 month age

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2018

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

June 14, 2017

First Submitted That Met QC Criteria

June 23, 2017

First Posted (Actual)

June 26, 2017

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POPB-TOX RB15.050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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