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Completed

NCT Number: NCT04337697

Neonatal Seizure Registry - Developmental Functional EValuation

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.

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Key information

Conditions

Neonatal Seizure Brain Damage, Chronic Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Palsy Cerebrovascular Disorders Epilepsy Hemorrhage Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Hypoxic-Ischemic Encephalopathy Intellectual Disability Intracranial Hemorrhages Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Stroke Vascular Diseases

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Boston Children's Hospital
  • Children's Hospital Medical Center, Cincinnati
  • Children's Hospital of Philadelphia
  • Children's National Research Institute
  • Duke University
  • Massachusetts General Hospital
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • Stanford University
  • University of Michigan

Registry information

Acronym: NSR-DEV

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2020
Registry last updated
Feb 5, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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