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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03560999
Recruitment Status : Active, not recruiting
First Posted : June 19, 2018
Last Update Posted : May 11, 2022
Sponsor:
Information provided by (Responsible Party):
Michelle James, Shriners Hospitals for Children

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.

Condition or disease
Brachial Plexus Palsy Due to Birth Trauma Injury Newborn

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   0 Days to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Shriners Hospitals for Children
  Study Documents (Full-Text)

Documents provided by Michelle James, Shriners Hospitals for Children:
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Responsible Party: Michelle James, Chief of Orthopaedic Surgery, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT03560999    
Other Study ID Numbers: NCA1703
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: May 11, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be coded and stored in a secured locked office. PHI will not be reused or disclosed to any other person or entity, except as required by law or for authorized oversight of the research project. Any disseminated data will be aggregated and coded.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Birth Injuries
Infant, Newborn, Diseases
Wounds and Injuries