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Tests treatment safety and results for Obstetrical Brachial Plexus Palsy
Official title Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
ClinicalTrials.gov ID: NCT03198702
What this study is testing
What is Botulinum toxin type A injection?
Botulinum toxin type A injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for obstetrical brachial plexus palsy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 11
You may be able to join if
- 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...
- Signature of the consent form by (the) parent(s) over the age of majority
You likely can't join if
- 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
See the full eligibility 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...
- Signature of the consent form by (the) parent(s) over the age of majority
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brest, France
- Flavigny-sur-Moselle, France
- Nantes, France
- Nîmes, France
- Rennes, France
- Saint-Etienne, France
- Saint-Maurice, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 months to 11 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brest, France; Flavigny-sur-Moselle, France; Nantes, France; Nîmes, France; Rennes, France; Saint-Etienne, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.