Study on Botulinum Toxin Type A for Preventing Shoulder Deformity in Infants with Brachial Plexus Palsy

3 1 1

What is this study about?

This clinical trial is focused on studying a condition known as Obstetrical Brachial Plexus Palsy, which affects infants. This condition can lead to shoulder deformities due to nerve damage that occurs during birth. The study is investigating the use of a treatment called Botulinum Toxin Type A, commonly known as Botox, to prevent these shoulder deformities. Botox is a substance that can help relax muscles and is being tested to see if it can prevent the worsening of shoulder joint issues in affected infants.

The purpose of the study is to evaluate how effective early injections of Botox are in preventing shoulder deformities in infants with this condition. The study involves giving Botox injections to the shoulder muscles of infants at 12 months of age and observing the effects over time. The study will compare the results of infants who receive Botox with those who receive a placebo, which is a substance with no active treatment. The main focus is on preventing the worsening of a specific shoulder joint issue called posterior glenohumeral joint subluxation, which is a partial dislocation of the shoulder joint.

Throughout the study, the infants will be monitored to see how their shoulder joints develop and to assess any changes in their movement abilities. The study will also track any side effects or adverse events that may occur. The goal is to determine if Botox can be a safe and effective treatment option for preventing shoulder deformities in infants with Obstetrical Brachial Plexus Palsy.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This involves checking the age and specific conditions of the infant, such as unilateral obstetrical brachial plexus palsy and certain risk factors for shoulder issues.

Eligibility criteria include being between 10 and 11 months old and having specific limitations in shoulder movement or muscle activity.

2 baseline measurements

Baseline measurements are taken to assess the current condition of the shoulder. This includes an MRI scan to evaluate the position of the humeral head and other shoulder structures.

3 treatment administration

At 12 months of age, the infant receives an intramuscular injection of botulinum toxin type a into the shoulder muscles. This is intended to prevent worsening of shoulder deformity.

The injection is administered as a solution for injection and is part of a controlled trial to compare its effects with a control group.

4 follow-up assessments

Follow-up assessments occur over the next six months. These include MRI scans to monitor changes in the shoulder joint and muscle condition.

The assessments also track changes in joint movement, muscle activity, and any adverse events.

5 final evaluation

At 18 months of age, a final evaluation is conducted. This includes another MRI scan to assess the evolution of the shoulder condition.

The results are compared to the baseline measurements to determine the effectiveness of the treatment.

6 long-term follow-up

Long-term follow-up is planned to monitor the child’s development and any surgical interventions up to the age of 10 years.

This follow-up is part of routine clinical practice and aims to ensure ongoing health and development.

Who Can Join the Study?

Babies, both boys and girls, with a condition called Obstetrical Brachial Plexus Palsy. This is a type of injury that affects the nerves in the shoulder area.
Babies must be older than 10 months but younger than 11 months.
The affected shoulder must show one of these two signs:
- A reduced ability to rotate the shoulder outward compared to the other shoulder by at least 10 degrees.
- A score below 6 on the Active Movement Scale (AMS) for certain movements. The AMS is a way to measure how well a baby can move their arm.
The baby’s parents must give their consent for participation in the study.

Who Cannot Join the Study?

Infants who do not have Obstetrical Brachial Plexus Palsy. This is a condition that affects the nerves in the shoulder area, usually occurring during birth.
Infants who are not between 11 and 18 months of age.
Infants who have already received treatment with botulinum toxin for their shoulder condition. Botulinum toxin is a substance used to relax muscles.
Infants with other medical conditions that might interfere with the study.
Infants whose parents or guardians do not agree to participate in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Ihqospvq Reybpelo dp Rpshiywaqxsu Cdidxc df Rdjcvzuhprkl pars eiymxp Fojjgyttifhmewfdswhe	Flavigny-sur-Moselle	France
Hgqkrbuv Pxaqr Eds Viwjuubjzxqi	Saint-Maurice	France
Itxvubrx da Chkragrkdmjo Hmywsdvbylk Uerqhofuocuvn dc Syqri Enqjyoi (gzrjjer	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	17.05.2018

Trial locations

Investigated drugs:

Botulinum Toxin is used in this trial to help prevent shoulder deformity in infants with a condition called obstetric brachial plexus palsy. The medication is injected into the shoulder muscles to see if it can stop the shoulder joint from moving out of place as the child grows. The goal is to see if these injections can help keep the shoulder joint in a better position and improve movement.

Obstetrical Brachial Plexus Palsy – This condition occurs when there is an injury to the brachial plexus nerves during childbirth, affecting the shoulder, arm, and hand. It can lead to weakness or paralysis in the affected arm, with varying degrees of severity. As the child grows, the condition may result in limited movement and muscle development in the shoulder and arm. Over time, some children may experience improvement in function, while others may have persistent difficulties. The condition can also lead to joint issues, such as subluxation, where the joint is partially dislocated. Early intervention and therapy are crucial to help improve movement and function in the affected limb.

Trial ID:

2024-520391-10-01

Protocol code:

POPBTOX

NCT ID:

NCT03198702

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Botulinum Toxin Type A for Preventing Shoulder Deformity in Infants with Brachial Plexus Palsy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?