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

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ClinicalTrials.gov Identifier: NCT03198702
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief 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.


Condition or disease Intervention/treatment Phase
Obstetrical Brachial Plexus Palsy Drug: Botulinum toxin type A injection Other: Sham Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

First group or "toxin" group: the babies will receive BOTOX injections at the age of 12 months in the shoulder muscles.

Second group or "sham" group:the babies receive the same procedure but no injection.

Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
Actual Study Start Date : May 17, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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)

  5. 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).



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Ages Eligible for Study:   10 Months to 11 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198702


Contacts
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Contact: Sylvain Brochard, Pr (+33) 02 98 22.33.73 sylvain.brochard@chu-brest.fr

Locations
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France
CHRU Brest Recruiting
Brest, France, 29609
Contact: Sylvain BROCHARD, Pr    02 98 22 33 73      
Contact: Chritelle PONS, Dr    02 98 22 33 73      
Principal Investigator: Sylvain BROCHARD, Pr         
Sub-Investigator: Christelle PONS, Dr         
Institut Régionnal de Réadaptation Centre de Réadaptation pour enfant Not yet recruiting
Flavigny-sur-Moselle, France, 54630
Contact: Emilie RUMILLY, Dr    03 83 85 85 85      
Contact: Jennifer BASTIEN, Dr         
Principal Investigator: Emilie RUMILLY, Dr         
Sub-Investigator: Jennifer BASTIEN, Dr         
CHU Nîmes Not yet recruiting
Nîmes, France, 30029
Contact: Mélanie PORTE, Dr    04 66 68 68 68      
Principal Investigator: Mélanie PORTE, Dr         
CHU Rennes Not yet recruiting
Rennes, France, 35033
Contact: Philippe VIOLAS, Dr    02 99 28 43 21      
Principal Investigator: Philippe VIOLAS, Dr         
Sub-Investigator: Helene RAUSCENT, Dr         
Sub-Investigator: Floriane COLIN, Dr         
CHU St Etienne Not yet recruiting
Saint Etienne, France, 42055
Contact: Madeleine ASLAN, Dr    04 77 82 80 37    madeleine.aslan@chu-st-etienne.fr   
Contact: Vincent GAUTHERON, Pr    04 77 82 80 00    vincent.gautheron@chu-st-etienne.fr   
Sub-Investigator: Vincent GAUTHERON, Pr         
Principal Investigator: Madeleine ASLAN, Dr         
Sub-Investigator: Bruno DOHIN, Pr         
Hôpital national de saint maurice Recruiting
Saint-Maurice, France, 94410
Contact: Nathaly QUINTERO, Dr    01 43 96 63 50    n.quintero@hopitaux-st-maurice.fr   
Contact: Anne-Gaëlle PY, Dr       ag.py@hopitaux-st-maurice.fr   
Principal Investigator: Nathaly QUINTERO, Dr         
Sub-Investigator: Anne-Gaëlle PYDr, Dr         
Sub-Investigator: Katherine SANCHEZ, Dr         
Sponsors and Collaborators
University Hospital, Brest

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03198702    
Other Study ID Numbers: POPB-TOX RB15.050
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Brest:
physiotherapy
children
shoulder deformation
obstetrical brachial plexus palsy
Additional relevant MeSH terms:
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Paralysis
Neonatal Brachial Plexus Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brachial Plexus Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Birth Injuries
Infant, Newborn, Diseases
Wounds and Injuries
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents