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

NCT03560999 | Unknown

• 1 other identifier: NCA1703
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Brachial Plexus Palsy Due to Birth Trauma; Injury; Newborn

Outcome Measures

Primary Outcomes (1)

• Whether Surgery Occurs

  The primary endpoint is the surgeon's decision for or against surgery, typically made by 6 months of age. Surgeons will make their decision based on all available clinical data, including the MRI, but will be blinded to the neuroradiologist's scoring of the SRS and its components.

  by 6 months of age

Secondary Outcomes (3)

• Intraoperative Findings

  At time of surgery. Surgery occurs solely due to clinical reasons, so surgery timing (if it occurs at all) varies based on the clinical needs of the patient.

• AMS Scores (Hospital for Sick Children Active Movement Scale)

  At follow up visits up to 30 months of age

• Toronto Scores

  At follow up visits up to 30 months of age

Eligibility Criteria

• Age: 0 Days - 12 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

This is a multicenter prospective cohort study of patients with BPBP. The study takes place at Shriners Hospitals for Children - Northern California, Boston Children's Hospital, and Gillette Children's Specialty Healthcare. All infants with BPBP between 0 and 12 weeks of age who present for treatment to a participating site will be offered participation in this study. Those infants with concomitant birth injuries that would make positioning in the MRI scanner difficult or painful (such as a birth humerus or clavicle fracture) will have their enrollment deferred. If the injury heals and the MRI can be performed within the required age range, they may be included in the study. If not, they will be excluded. Those infants who attempt to complete or actually complete the MRI scan but end up with unusable images will continue to be followed clinically, but will be removed from participation in this study.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shriners Hospitals for Children: lead

Study Sites (3)

Shriners Hospitals for Children - Northern California

Sacramento, California, 95817, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Orthopaedic Surgery

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: June 19, 2018
• Study Start: March 11, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)