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

Newborn Clinical Trial

— NAPTIME  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03560999
• Other study ID #: NCA1703
• Status: Active, not recruiting
• Start date: March 11, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 12 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Birth Injuries
• Brachial Plexus Palsy Due to Birth Trauma
• Injury
• Newborn

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Shriners Hospitals for Children - Northern California	Sacramento	California
United States	Gillette Children's Specialty Healthcare	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether Surgery Occurs	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.	by 6 months of age
Secondary	Intraoperative Findings	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.	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.
Secondary	AMS Scores (Hospital for Sick Children Active Movement Scale)	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.	At follow up visits up to 30 months of age
Secondary	Toronto Scores	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).	At follow up visits up to 30 months of age