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Quick MRI could spare babies unnecessary surgery or speed up needed treatment

NCT ID NCT03560999

Diagnosis Sponsor: Shriners Hospitals for Children Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new, rapid MRI method in 102 infants with brachial plexus birth palsy (nerve damage from birth). The goal was to see if the MRI could help doctors decide earlier and more accurately whether the baby needs nerve surgery. The MRI was done without anesthesia, and the results were compared to what surgeons found during actual operations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

102 people

The number who actually took part.

Started

Mar 2017

Finished

Mar 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

0 days to 12 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Erb palsy injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brachial plexus palsy due to birth trauma INJURY Newborn

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Gillette Children's Specialty Healthcare

    Saint Paul, Minnesota, 55101, United States

  • Shriners Hospitals for Children - Northern California

    Sacramento, California, 95817, United States

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