Non-Anesthetized Plexus Technique for Infant (BPBP) MRI Evaluation

NCT ID: NCT03560999

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-11
• Study Completion Date: 2024-12-31

Brief Summary

The investigators are studying the ability of a novel rapid magnetic resonance imaging (MRI) protocol to provide more accurate and earlier information about whether an infant with brachial plexus birth palsy will require nerve surgery.

Detailed Description

Brachial plexus birth palsy (BPBP) affects approximately 1 in 1,000 newborns, and though the majority of infants regain full function of the affected arm without nerve surgery, those with more severe nerve root injuries will require it. Currently, the best way to determine who will need surgery is to measure the trajectory of muscle recovery by serial clinical exams, but the optimal time for nerve surgery (before 3 months of age) is earlier than the time it usually takes to determine whether the infant needs surgery (up to 6 months.) A non-invasive diagnostic test that identifies the more severe injuries that require surgery earlier than serial exams would improve treatment timing, planning, and accuracy, and ultimately outcomes.

The investigators have developed a rapid MRI sequence with high spatial resolution and soft tissue contrast that does not require sedation or injection of a contrast agent, and that appeared to accurately assess the severity of nerve injury in infants with BPBP in a pilot study. This pilot study demonstrated that the protocol distinguishes infants who ultimately needed surgery from those who recovered spontaneously. The purpose of the current study is to enroll 100 infants at 3 centers (Shriners Hospital for Children Northern California, Boston Children's Hospital, and Gillette Children's Hospital) over a 5 year period to validate this imaging protocol as the new "gold standard" to determine whether infants with BPBP need surgery, so that individuals who need it could have surgery earlier when it is more effective, and the parents of the majority who will recover spontaneously could be spared months of worry.

Conditions

Brachial Plexus Palsy Due to Birth Trauma; Injury; Newborn

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of brachial plexus birth palsy.
• Age at consent ≤4 months

Exclusion Criteria

• Bilateral brachial plexus birth palsy.
• Age at MRI <28 days or >4 months old (patients can be enrolled prior to 28 days of age, but the imaging must occur in the 28 days to 4 months' time period). The lead PI will need to approve the enrollment of a subject who will have the MRI after 90 days of age.
• Concomitant medical conditions that would preclude performance of or confound interpretation of MRI or any clinical assessment.

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shriners Hospitals for Children

OTHER

Sponsor Role: lead

Responsible Party

Michelle James

Chief of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shriners Hospitals for Children - Northern California

Sacramento, California, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCA1703

Identifier Type: -

Identifier Source: org_study_id