Non-Anesthetized Plexus Technique for Infant (BPBP) MRI Evaluation
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | Any |
Updated: | 6/21/2018 |
Start Date: | March 11, 2017 |
End Date: | January 31, 2023 |
Multi-Center: Non-Anesthetized Plexus Technique for Infant (BPBP) MRI Evaluation
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.
protocol to provide more accurate and earlier information about whether an infant with
brachial plexus birth palsy will require nerve surgery.
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.
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.
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.
We found this trial at
3
sites
300 Longwood Ave
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Andrea Bauer, MD
Phone: 617-919-6064
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Sacramento, California 95817
Principal Investigator: Michelle James, MD
Phone: 916-453-2000
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Saint Paul, Minnesota 55101
Principal Investigator: Ann Van Heest, MD
Phone: 651-290-8707
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