Quick MRI could spare babies unnecessary surgery or speed up needed treatment
NCT ID NCT03560999
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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102 people
The number who actually took part.
- Started
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Mar 2017
- Finished
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Mar 2024
- Lead sponsor
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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
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0 days to 12 weeks
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Boston Children's Hospital
Boston, Massachusetts, 02115, United States
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Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, 55101, United States
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Shriners Hospitals for Children - Northern California
Sacramento, California, 95817, United States
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