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

• ClinicalTrials.gov Identifier: NCT04337697
• Recruitment Status: Recruiting
• First Posted: April 8, 2020
• Last Update Posted: June 24, 2021
• Sponsor: University of California, San Francisco
• 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

Study Description

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.

Study Design

• 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

Groups and Cohorts

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Hannah C. Glass, MDCM, MAS; 415-476-3785; Hannah.glass@ucsf.edu

Contact: Yasmeen A. Rezaishad, BS; 415-476-3785; Yasmeen.rezaishad@ucsf.edu

Locations

United States, California

University of California, San Francisco; Recruiting

San Francisco, California, United States, 94158

Contact: Yasmeen A. Rezaishad, BS 415-476-3785 yasmeen.rezaishad@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; 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: Caitlin Stone, MA 919-668-1775 caitlin.stone@duke.edu

Principal Investigator: Monica E. Lemmon, MD

United States, Ohio

Cincinnati Children's Hospital Medical Center; Recruiting

Cincinnati, Ohio, United States, 45229

Contact: Victor LaFay, MBA, CCRP 513-803-1988 victor.lafay@cchmc.org

Principal Investigator: Cameron Thomas, MD, MS

United States, Pennsylvania

Children's Hospital of Philadelphia; 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

• Principal Investigator: Hannah C. Glass, MDCM, MAS; University of California, San Francisco

More Information

• 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
• Last Update Posted: June 24, 2021
• Last Verified: June 2021

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

• 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:

Cerebral Palsy; Seizures; Brain Diseases; Intellectual Disability; Brain Ischemia; Hypoxia-Ischemia, Brain; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Mental Disorders; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hypoxia, Brain