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Neonatal Seizure Registry - Developmental Functional EValuation (NSR-DEV)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04337697
Recruitment Status : Recruiting
First Posted : April 8, 2020
Last Update Posted : July 8, 2020
Sponsor:
Collaborators:
University of Michigan
Stanford University
Duke University
Boston Children’s Hospital
Children's National Research Institute
Massachusetts General Hospital
Children's Hospital of Philadelphia
Children's Hospital Medical Center, Cincinnati
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The NSR-DEV study is a longitudinal cohort study of around 280 Neonatal Seizure Registry participants that aims to evaluate childhood outcomes after acute symptomatic neonatal seizures, as well as examine risk factors for developmental disabilities and whether these are modified by parent well-being.

Condition or disease
Neonatal Seizure Hypoxic-Ischemic Encephalopathy Stroke Intracranial Hemorrhages Epilepsy Cerebral Palsy Intellectual Disability

Detailed Description:

Neonatal seizures due to brain injury (acute symptomatic seizures) are associated with high risk of neurodevelopmental disability in infancy. Although prognosis in early childhood is a critical question for parents and providers, outcomes beyond infancy are largely unknown. Further, parents of infants with neonatal seizures are at risk for mental health disorders, which can undermine their ability to care for a child with medical complexity and may contribute to impaired child development.

The NSR-DEV study is a longitudinal cohort study of around 280 Neonatal Seizure Registry participants enrolled at one of nine sites across the USA. Participants will be evaluated using developmental questionnaires and in-person neurodevelopmental testing. Parent well-being will be assessed at each time point.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 280 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: Neonatal Seizure Registry - Developmental Functional EValuation
Actual Study Start Date : March 15, 2020
Estimated Primary Completion Date : February 29, 2024
Estimated Study Completion Date : February 29, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures




Primary Outcome Measures :
  1. Full scale IQ (FSIQ) score for each child on the Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI-IV) [ Time Frame: At age 5.5 years during in-person study visit ]
    The WPPSI-IV is an in-person assessment administered by a psychologist or psychometrician that will be used to measure neurocognitive ability. Full Scale IQ (FSIQ) will be generated for each participant from the following subtests: Verbal Comprehension Index (VCI), Visual Spatial Index (VSI), Fluid Reasoning Index (FRI), Working Memory Index (WMI), Processing Speed Index (PSI), Receptive Vocabulary and Picture Naming.


Secondary Outcome Measures :
  1. Change in scores over time for each child on the Vineland Adaptive Behavior Scales, 3rd Edition [ Time Frame: At enrollment study visit and annual visits when the child is age 3, 4, 5.5, 7, and 8 ]
    The Vineland Adaptive Behavior Scales Parent Form measures adaptive behavior and intellectual and developmental function. Adaptive behavior is predictive of functional performance in school and is linked to both cognitive and executive function. Scores for each participant at each timepoint are generated based on parent reports in the following categories: Communication, Daily Living Skills, Socialization, Motor Skills, Adaptive Behavior Composite (ABC). We will look at the change in score over time for each participant during the study period after the Vineland-3 is administered at each timepoint.


Other Outcome Measures:
  1. Scores for each child on Behavior Rating Inventory of Executive Function®, Preschool version (BRIEF-P) [ Time Frame: At enrollment study visit ]
    BRIEF-P is a standardized measure of early childhood executive function. Scores are generated based on parent report of a child's function in the Global Executive Composite (GBC) scale.

  2. Scores for each child on Behavior Rating Inventory of Executive Function®, Preschool version (BRIEF-P) [ Time Frame: At age 5.5 years during in-person study visit ]
    BRIEF-P is a standardized measure of early childhood executive function. Scores are generated based on parent report of a child's function in the Global Executive Composite (GBC) scale.

  3. Scores for each child on The Social Responsiveness Scale, 2nd edition (SRS-2) - Parent Form [ Time Frame: At enrollment study visit ]
    SRS-2 (Parent Form) is an online tool to identify social impairment associated with Autism Spectrum Disorders and quantifies Autism Spectrum Disorder severity. Scores are generated based on parent report of child's function in these scales: Social Awareness, Social Cognition, Social Communication, Social Motivation, Restricted Behaviors and Repetitive Behavior. A total score as well as separate scale scores are generated.

  4. Scores for each child on The Social Responsiveness Scale, 2nd edition (SRS-2) - Parent Form [ Time Frame: At age 5.5 years during in-person study visit ]
    SRS-2 (Parent Form) is an online tool to identify social impairment associated with Autism Spectrum Disorders and quantifies Autism Spectrum Disorder severity. Scores are generated based on parent report of child's function in these scales: Social Awareness, Social Cognition, Social Communication, Social Motivation, Restricted Behaviors and Repetitive Behavior. A total score as well as separate scale scores are generated.

  5. Scores for each child on The Social Responsiveness Scale, 2nd edition (SRS-2) - Teacher Form [ Time Frame: At age 5.5 years during in-person study visit ]
    SRS-2 (Teacher Form) is an online tool to identify social impairment associated with Autism Spectrum Disorders and quantifies Autism Spectrum Disorder severity. Scores are generated based on teacher report of child's function in these scales: Social Awareness, Social Cognition, Social Communication, Social Motivation, Restricted Behaviors and Repetitive Behavior. A total score as well as separate scale scores are generated.

  6. Scores for each child on Behavior Assessment System for Children, 3rd edition (BASC-3) - Parent Form [ Time Frame: At enrollment study visit ]
    BASC-3 (Parent Form) is a measure of both adaptive and problem behaviors. Scores are generated based on parent report of a child's behavior in these scales: Externalizing Problems, Internalizing Problems, Adaptive Skills, Hyperactivity, Attention Problems, Atypicality, and Social Skills.

  7. Scores for each child on Behavior Assessment System for Children, 3rd edition (BASC-3) - Parent Form [ Time Frame: At age 5.5 years during in-person study visit ]
    BASC-3 (Parent Form) is a measure of both adaptive and problem behaviors. Scores are generated based on parent report of a child's behavior in these scales: Externalizing Problems, Internalizing Problems, Adaptive Skills, Hyperactivity, Attention Problems, Atypicality, and Social Skills.

  8. Scores for each child on Behavior Assessment System for Children, 3rd edition (BASC-3) - Teacher Form [ Time Frame: At age 5.5 years during in-person study visit ]
    BASC-3 (Teacher Form) is a measure of both adaptive and problem behaviors. Scores are generated based on teacher report of a child's behavior in these scales: Externalizing Problems, Internalizing Problems, Behavior Symptoms Index, Adaptive Skills, School Problems, Hyperactivity, Attention Problems, Atypicality, and Social Skills.

  9. Scores for each child on Child Sensory Profile, 2nd edition - Parent Form [ Time Frame: At enrollment study visit ]
    Child Sensory Profile, 2nd edition (Parent Form) is a standardized instrument to evaluate sensory processing issues, including oversensitivity to sights, sounds, textures, and other sensory input. Scores are generated based on parent report of child's processing in these areas: Seeking/Seeker, Avoiding/Avoider, Sensitivity/Sensor, Registration/Bystander, Auditory Processing, Visual Processing, Touch Processing, Movement Processing, Body Position Processing, and Oral Sensory Processing.

  10. Scores for each child on Child Sensory Profile, 2nd edition - Parent Form [ Time Frame: At age 5.5 years during in-person study visit ]
    Child Sensory Profile, 2nd edition (Parent Form) is a standardized instrument to evaluate sensory processing issues, including oversensitivity to sights, sounds, textures, and other sensory input. Scores are generated based on parent report of child's processing in these areas: Seeking/Seeker, Avoiding/Avoider, Sensitivity/Sensor, Registration/Bystander, Auditory Processing, Visual Processing, Touch Processing, Movement Processing, Body Position Processing, and Oral Sensory Processing.

  11. Scores for each child on Kaufman Test of Educational Achievement, 3rd edition (KTEA-3) [ Time Frame: At age 5.5 years during in-person study visit ]
    KTEA-3 is a standardized instrument that provides in-depth assessment and evaluation of key academic skills. Scores are generated based on child performance in these areas: Spelling, Letter and Word Recognition and Math Computation.

  12. Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS) [ Time Frame: At enrollment study visit ]
    Hospital Anxiety Depression Scale (HADS) is a well-validated, 14-item, measure of symptoms of anxiety and depression. Scores will be generated based on parent/guardian response to the HADS questionnaire.

  13. Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS) [ Time Frame: At (child) age 3 years during annual study visit ]
    Hospital Anxiety Depression Scale (HADS) is a well-validated, 14-item, measure of symptoms of anxiety and depression. Scores will be generated based on parent/guardian response to the HADS questionnaire.

  14. Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS) [ Time Frame: At (child) age 4 years during annual study visit ]
    Hospital Anxiety Depression Scale (HADS) is a well-validated, 14-item, measure of symptoms of anxiety and depression. Scores will be generated based on parent/guardian response to the HADS questionnaire.

  15. Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS) [ Time Frame: At (child) age 5.5 years during in-person study visit ]
    Hospital Anxiety Depression Scale (HADS) is a well-validated, 14-item, measure of symptoms of anxiety and depression. Scores will be generated based on parent/guardian response to the HADS questionnaire.

  16. Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS) [ Time Frame: At (child) age 7 years during annual study visit ]
    Hospital Anxiety Depression Scale (HADS) is a well-validated, 14-item, measure of symptoms of anxiety and depression. Scores will be generated based on parent/guardian response to the HADS questionnaire.

  17. Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS) [ Time Frame: At (child) age 8 years during annual study visit ]
    Hospital Anxiety Depression Scale (HADS) is a well-validated, 14-item, measure of symptoms of anxiety and depression. Scores will be generated based on parent/guardian response to the HADS questionnaire.

  18. Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: At enrollment study visit ]
    WHO Quality of Life-BREF (WHOQOL-BREF) assesses four domains of health: physical, psychological, social relationships, and environment. It also includes two general questions on self-perceived QOL and general health. Scores will be generated based on parent/guardian response to the WHOQOL-BREF questionnaire.

  19. Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: At (child) age 3 years during annual study visit ]
    WHO Quality of Life-BREF (WHOQOL-BREF) assesses four domains of health: physical, psychological, social relationships, and environment. It also includes two general questions on self-perceived QOL and general health. Scores will be generated based on parent/guardian response to the WHOQOL-BREF questionnaire.

  20. Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: At (child) age 4 years during annual study visit ]
    WHO Quality of Life-BREF (WHOQOL-BREF) assesses four domains of health: physical, psychological, social relationships, and environment. It also includes two general questions on self-perceived QOL and general health. Scores will be generated based on parent/guardian response to the WHOQOL-BREF questionnaire.

  21. Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: At (child) age 5.5 years during in-person study visit ]
    WHO Quality of Life-BREF (WHOQOL-BREF) assesses four domains of health: physical, psychological, social relationships, and environment. It also includes two general questions on self-perceived QOL and general health. Scores will be generated based on parent/guardian response to the WHOQOL-BREF questionnaire.

  22. Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: At (child) age 7 years during annual study visit ]
    WHO Quality of Life-BREF (WHOQOL-BREF) assesses four domains of health: physical, psychological, social relationships, and environment. It also includes two general questions on self-perceived QOL and general health. Scores will be generated based on parent/guardian response to the WHOQOL-BREF questionnaire.

  23. Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: At (child) age 8 years during annual study visit ]
    WHO Quality of Life-BREF (WHOQOL-BREF) assesses four domains of health: physical, psychological, social relationships, and environment. It also includes two general questions on self-perceived QOL and general health. Scores will be generated based on parent/guardian response to the WHOQOL-BREF questionnaire.

  24. Scores for each parent/guardian on The Impact on Family Scale (IOF) [ Time Frame: At enrollment study visit ]
    The Impact on Family Scale (IOF) measures parent perception of the ill child's impact on the family. The score represents a construct of personal, family and social impact. Scores will be generated based on parent/guardian response to the IOF questionnaire.

  25. Scores for each parent/guardian on The Impact on Family Scale (IOF) [ Time Frame: At (child) age 3 years during annual study visit ]
    The Impact on Family Scale (IOF) measures parent perception of the ill child's impact on the family. The score represents a construct of personal, family and social impact. Scores will be generated based on parent/guardian response to the IOF questionnaire.

  26. Scores for each parent/guardian on The Impact on Family Scale (IOF) [ Time Frame: At (child) age 4 years during annual study visit ]
    The Impact on Family Scale (IOF) measures parent perception of the ill child's impact on the family. The score represents a construct of personal, family and social impact. Scores will be generated based on parent/guardian response to the IOF questionnaire.

  27. Scores for each parent/guardian on The Impact on Family Scale (IOF) [ Time Frame: At (child) age 5.5 years during in-person study visit ]
    The Impact on Family Scale (IOF) measures parent perception of the ill child's impact on the family. The score represents a construct of personal, family and social impact. Scores will be generated based on parent/guardian response to the IOF questionnaire.

  28. Scores for each parent/guardian on The Impact on Family Scale (IOF) [ Time Frame: At (child) age 7 years during annual study visit ]
    The Impact on Family Scale (IOF) measures parent perception of the ill child's impact on the family. The score represents a construct of personal, family and social impact. Scores will be generated based on parent/guardian response to the IOF questionnaire.

  29. Scores for each parent/guardian on The Impact on Family Scale (IOF) [ Time Frame: At (child) age 8 years during annual study visit ]
    The Impact on Family Scale (IOF) measures parent perception of the ill child's impact on the family. The score represents a construct of personal, family and social impact. Scores will be generated based on parent/guardian response to the IOF questionnaire.

  30. Scores for each parent/guardian on The Impact of Events Scale - Revised [ Time Frame: At enrollment study visit ]
    The Impact of Events Scale - Revised is a validated measure of post-traumatic stress reactions. Scores will be generated based on parent/guardian response to the Impact of Events Scale - Revised questionnaire.

  31. Scores for each parent/guardian on The Impact of Events Scale - Revised [ Time Frame: At (child) age 3 years during annual study visit ]
    The Impact of Events Scale - Revised is a validated measure of post-traumatic stress reactions. Scores will be generated based on parent/guardian response to the Impact of Events Scale - Revised questionnaire.

  32. Scores for each parent/guardian on The Impact of Events Scale - Revised [ Time Frame: At (child) age 4 years during annual study visit ]
    The Impact of Events Scale - Revised is a validated measure of post-traumatic stress reactions. Scores will be generated based on parent/guardian response to the Impact of Events Scale - Revised questionnaire.

  33. Scores for each parent/guardian on The Impact of Events Scale - Revised [ Time Frame: At (child) age 5.5 years during in-person study visit ]
    The Impact of Events Scale - Revised is a validated measure of post-traumatic stress reactions. Scores will be generated based on parent/guardian response to the Impact of Events Scale - Revised questionnaire.

  34. Scores for each parent/guardian on The Impact of Events Scale - Revised [ Time Frame: At (child) age 7 years during annual study visit ]
    The Impact of Events Scale - Revised is a validated measure of post-traumatic stress reactions. Scores will be generated based on parent/guardian response to the Impact of Events Scale - Revised questionnaire.

  35. Scores for each parent/guardian on The Impact of Events Scale - Revised [ Time Frame: At (child) age 8 years during annual study visit ]
    The Impact of Events Scale - Revised is a validated measure of post-traumatic stress reactions. Scores will be generated based on parent/guardian response to the Impact of Events Scale - Revised questionnaire.

  36. Scores for each parent/guardian on The Post Traumatic Growth Inventory [ Time Frame: At enrollment study visit ]
    The Post Traumatic Growth Inventory is a commonly used, validated measure of resilience that has been incorporated into studies of parents of sick neonates and children. Scores will be generated based on parent/guardian response to The Post Traumatic Growth Inventory questionnaire.

  37. Scores for each parent/guardian on The Post Traumatic Growth Inventory [ Time Frame: At (child) age 3 years during annual study visit ]
    The Post Traumatic Growth Inventory is a commonly used, validated measure of resilience that has been incorporated into studies of parents of sick neonates and children. Scores will be generated based on parent/guardian response to The Post Traumatic Growth Inventory questionnaire.

  38. Scores for each parent/guardian on The Post Traumatic Growth Inventory [ Time Frame: At (child) age 4 years during annual study visit ]
    The Post Traumatic Growth Inventory is a commonly used, validated measure of resilience that has been incorporated into studies of parents of sick neonates and children. Scores will be generated based on parent/guardian response to The Post Traumatic Growth Inventory questionnaire.

  39. Scores for each parent/guardian on The Post Traumatic Growth Inventory [ Time Frame: At (child) age 5.5 years during in-person study visit ]
    The Post Traumatic Growth Inventory is a commonly used, validated measure of resilience that has been incorporated into studies of parents of sick neonates and children. Scores will be generated based on parent/guardian response to The Post Traumatic Growth Inventory questionnaire.

  40. Scores for each parent/guardian on The Post Traumatic Growth Inventory [ Time Frame: At (child) age 7 years during annual study visit ]
    The Post Traumatic Growth Inventory is a commonly used, validated measure of resilience that has been incorporated into studies of parents of sick neonates and children. Scores will be generated based on parent/guardian response to The Post Traumatic Growth Inventory questionnaire.

  41. Scores for each parent/guardian on The Post Traumatic Growth Inventory [ Time Frame: At (child) age 8 years during annual study visit ]
    The Post Traumatic Growth Inventory is a commonly used, validated measure of resilience that has been incorporated into studies of parents of sick neonates and children. Scores will be generated based on parent/guardian response to The Post Traumatic Growth Inventory questionnaire.

  42. Written responses from each parent/guardian on Open Ended Questions [ Time Frame: At enrollment study visit ]
    The Open Ended Questions ask parents/guardians to explain different aspects of caring for their child and their child's healthcare journey and for any advice they would give to both the healthcare team and other parents of children with similar conditions.

  43. Written responses from each parent/guardian on Open Ended Questions [ Time Frame: At (child) age 3 years during annual study visit ]
    The Open Ended Questions ask parents/guardians to explain different aspects of caring for their child and their child's healthcare journey and for any advice they would give to both the healthcare team and other parents of children with similar conditions.

  44. Written responses from each parent/guardian on Open Ended Questions [ Time Frame: At (child) age 4 years during annual study visit ]
    The Open Ended Questions ask parents/guardians to explain different aspects of caring for their child and their child's healthcare journey and for any advice they would give to both the healthcare team and other parents of children with similar conditions.

  45. Written responses from each parent/guardian on Open Ended Questions [ Time Frame: At (child) age 5.5 years during in-person study visit ]
    The Open Ended Questions ask parents/guardians to explain different aspects of caring for their child and their child's healthcare journey and for any advice they would give to both the healthcare team and other parents of children with similar conditions.

  46. Written responses from each parent/guardian on Open Ended Questions [ Time Frame: At (child) age 7 years during annual study visit ]
    The Open Ended Questions ask parents/guardians to explain different aspects of caring for their child and their child's healthcare journey and for any advice they would give to both the healthcare team and other parents of children with similar conditions.

  47. Written responses from each parent/guardian on Open Ended Questions [ Time Frame: At (child) age 8 years during annual study visit ]
    The Open Ended Questions ask parents/guardians to explain different aspects of caring for their child and their child's healthcare journey and for any advice they would give to both the healthcare team and other parents of children with similar conditions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatient, family members/caregivers, providers, children/minors, subjects unable to read, speak or understand English
Criteria

Inclusion Criteria:

  • Enrolled in NSR-II
  • Alive at the start of the NSR-DEV study period
  • Parent(s) who are English or Spanish literate (with assistance of interpreter)

Exclusion Criteria:

  • Neonates who were found to have exclusion criteria after NSR-II enrollment
  • Risk for adverse outcome independent of seizures and underlying brain injury (including but not limited to: inborn errors of metabolism, fetal infection, brain malformation)
  • Transient cause for seizures (e.g., mild hypoglycemia, hyponatremia, hypocalcemia with normal neuroimaging)
  • Neonatal-onset epilepsy syndromes

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): NCT04337697


Contacts
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Contact: Hannah C. Glass, MDCM, MAS 415-476-3785 Hannah.glass@ucsf.edu
Contact: Olivia A. Girvan, BS 415-476-3785 Olivia.girvan@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Olivia A. Girvan, BS    415-476-3785    olivia.girvan@ucsf.edu   
Principal Investigator: Hannah C. Glass, MDCM, MAS         
Sub-Investigator: Charles McCulloch, PhD         
Sub-Investigator: Elizabeth E. Rogers, MD         
Sub-Investigator: Linda S. Franck, PhD, RN, FAAN         
Sub-Investigator: Yi Li, MD         
Stanford University Recruiting
Stanford, California, United States, 94304
Contact: Sweta Patnaik, MS    650-721-1458    sweta@stanford.edu   
Principal Investigator: Courtney J. Wusthoff, MD         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Ruoying (Penny) Li    202-476-3807    rli@childrensnational.org   
Principal Investigator: Taeun Chang, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Erin Berja, BS    617-249-4939    eberja@mgh.harvard.edu   
Principal Investigator: Catherine Chu, MD         
Boston Children's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Jessica Landers, MS    617-355-0578    jessica.landers@childrens.harvard.edu   
Principal Investigator: Janet Soul, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Stephanie Rau, BS, CCRP    734-232-8474    shatchew@med.umich.edu   
Principal Investigator: Renee A. Shellhaas, MD, MS         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Grace Jefferson, MS    919-668-3873    grace.jefferson@duke.edu   
Principal Investigator: Monica E. Lemmon, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Joshua Lambert, MA    513-636-5511    joshua.lambert@cchmc.org   
Principal Investigator: Cameron Thomas, MD, MS         
United States, Pennsylvania
Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Darshana Parikh, BA       parikhd@email.chop.edu   
Principal Investigator: Nicholas Abend, MD, MSCE         
Sponsors and Collaborators
University of California, San Francisco
University of Michigan
Stanford University
Duke University
Boston Children’s Hospital
Children's National Research Institute
Massachusetts General Hospital
Children's Hospital of Philadelphia
Children's Hospital Medical Center, Cincinnati
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Hannah C. Glass, MDCM, MAS University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04337697    
Other Study ID Numbers: 19-28584
1R01NS111166-01A1 ( U.S. NIH Grant/Contract )
R01NS111166 ( U.S. NIH Grant/Contract )
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In accordance with study sponsor
Time Frame: In accordance with study sponsor
Access Criteria: In accordance with study sponsor

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Family impact
Neurodevelopment
Additional relevant MeSH terms:
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Seizures
Cerebral Palsy
Brain Diseases
Intellectual Disability
Brain Ischemia
Hypoxia-Ischemia, Brain
Intracranial Hemorrhages
Hemorrhage
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Brain Damage, Chronic
Neurobehavioral Manifestations
Neurodevelopmental Disorders
Mental Disorders
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain