Non-Anesthetized Plexus Technique for Infant (BPBP) MRI Evaluation (NAPTIME)
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|ClinicalTrials.gov Identifier: NCT03560999|
Recruitment Status : Active, not recruiting
First Posted : June 19, 2018
Last Update Posted : May 11, 2022
|Condition or disease|
|Brachial Plexus Palsy Due to Birth Trauma Injury Newborn|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Multi-Center: Non-Anesthetized Plexus Technique for Infant (BPBP) MRI Evaluation|
|Actual Study Start Date :||March 11, 2017|
|Estimated Primary Completion Date :||January 31, 2023|
|Estimated Study Completion Date :||January 31, 2023|
- Whether Surgery Occurs [ Time Frame: by 6 months of age ]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.
- Intraoperative Findings [ Time Frame: 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. ]The secondary outcome will be the surgeon's intraoperative findings during brachial plexus reconstructive microsurgery. Specifically, agreement between MRI and intraoperative findings, with respect to the level(s) and extent of injury of each nerve root and the location of root injury (pre- vs. post-ganglionic) will be determined.
- AMS Scores (Hospital for Sick Children Active Movement Scale) [ Time Frame: At follow up visits up to 30 months of age ]Active Movement Scale (AMS) measures the strength of 15 different muscles based on a scale of 0-7; 0 is no motion, and 7 is full motion against gravity.
- Toronto Scores [ Time Frame: At follow up visits up to 30 months of age ]The Toronto score also measures the strength of 15 different muscles based on a scale of 0-7; 0 is no motion, and 7 is full motion against gravity The Toronto score is a shorthand designation of the key AMS muscle strengths, in which these muscle strengths are combined (summed).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560999
|United States, California|
|Shriners Hospitals for Children - Northern California|
|Sacramento, California, United States, 95817|
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Minnesota|
|Gillette Children's Specialty Healthcare|
|Saint Paul, Minnesota, United States, 55101|