Brachial Plexus Palsy Due to Birth TraumaNAPTIMENCT03560999
Non-Anesthetized Plexus Technique for Infant (BPBP) MRI Evaluation
An observational study of Brachial Plexus Palsy Due to Birth Trauma and Injury, run by Shriners Hospitals for Children at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 0 days to 12 weeks
- Conditions the study is for
- Brachial Plexus Palsy Due to Birth Trauma, Injury, Newborn
- How many people
- 102 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Mar 2017to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 12 weeks
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Diagnosis of brachial plexus birth palsy.
- Age at consent ≤4 months
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Shriners Hospitals for Children - Northern California
Sacramento, California, 95817
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, 55101
About this study
Official title: 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.
Read the 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.
- Conditions
- Brachial Plexus Palsy Due to Birth Trauma, Injury, Newborn
- Medical subject headings
- Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: by 6 months of age
Secondary outcomes (3)
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.
Measured: 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.
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.
Measured: At follow up visits up to 30 months of age
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).
Measured: At follow up visits up to 30 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start11 Mar 2017
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus Palsy Due to Birth TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle James, Shriners Hospitals for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560999
- Sponsor's protocol ID
- NCA1703
- Acronym
- NAPTIME
- Status last verified
- Nov 2023
- First submitted
- 26 Apr 2018
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center: Non-Anesthetized Plexus Technique for Infant (BPBP) MRI Evaluation
- ClinicalTrials.gov ID
- NCT03560999
- Acronym / sponsor ID
- NAPTIME / NCA1703
- Conditions
- Brachial Plexus Palsy Due to Birth Trauma, Injury, Newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- 11 Mar 2017 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 days to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Diagnosis of brachial plexus birth palsy.
- Age at consent ≤4 months
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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.
AMS Scores (Hospital for Sick Children Active Movement Scale)
Time frame: At follow up visits up to 30 months of age
Toronto Scores
Time frame: At follow up visits up to 30 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Brachial Plexus Palsy Due to Birth Trauma
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RecruitingObservational study
Evaluation of Pain, Upper Extremity Function, and Social Appearance Anxiety in Adults With Obstetric Brachial Plexus Palsy Who Underwent Shoulder Tendon Transfer Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brachial Plexus Palsy Due to Birth Trauma and Injury, run by Shriners Hospitals for Children at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether Surgery Occurs (time frame: by 6 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.