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Completed

NCT Number: NCT03560999

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.

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Key information

Conditions

Brachial Plexus Palsy Due to Birth Trauma Injury Newborn Wounds and Injuries

Age range

0 day–12 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Shriners Hospitals for Children - Northern California, Sacramento, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Shriners Hospitals for Children

Other

Registry information

Official study title

Multi-Center: Non-Anesthetized Plexus Technique for Infant (BPBP) MRI Evaluation

Acronym: NAPTIME

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jun 19, 2018
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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