NSR-DEV: Neonatal Seizure Registry - Developmental Functional EValuation

Sponsor

University of California, San Francisco (Other)

Overall Status

Recruiting

CT.gov ID

NCT04337697

Collaborator

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

280

Enrollment

Locations

47.5

Anticipated Duration (Months)

31.1

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
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]

Anticipated Enrollment :

280 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Neonatal Seizure Registry - Developmental Functional EValuation

Actual Study Start Date :

Mar 15, 2020

Anticipated Primary Completion Date :

Feb 29, 2024

Anticipated Study Completion Date :

Feb 29, 2024

Outcome Measures

Primary Outcome Measures

Full scale IQ (FSIQ) score for each child on the Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI-IV) [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

Change in scores over time for each child on the Vineland Adaptive Behavior Scales, 3rd Edition [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

Scores for each child on Behavior Rating Inventory of Executive Function®, Preschool version (BRIEF-P) [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.
Scores for each child on Behavior Rating Inventory of Executive Function®, Preschool version (BRIEF-P) [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.
Scores for each child on The Social Responsiveness Scale, 2nd edition (SRS-2) - Parent Form [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.
Scores for each child on The Social Responsiveness Scale, 2nd edition (SRS-2) - Parent Form [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.
Scores for each child on The Social Responsiveness Scale, 2nd edition (SRS-2) - Teacher Form [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.
Scores for each child on Behavior Assessment System for Children, 3rd edition (BASC-3) - Parent Form [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.
Scores for each child on Behavior Assessment System for Children, 3rd edition (BASC-3) - Parent Form [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.
Scores for each child on Behavior Assessment System for Children, 3rd edition (BASC-3) - Teacher Form [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.
Scores for each child on Child Sensory Profile, 2nd edition - Parent Form [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.
Scores for each child on Child Sensory Profile, 2nd edition - Parent Form [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.
Scores for each child on Kaufman Test of Educational Achievement, 3rd edition (KTEA-3) [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.
Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS) [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.
Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS) [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.
Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS) [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.
Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS) [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.
Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS) [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.
Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS) [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.
Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF) [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.
Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF) [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.
Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF) [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.
Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF) [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.
Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF) [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.
Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF) [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.
Scores for each parent/guardian on The Impact on Family Scale (IOF) [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.
Scores for each parent/guardian on The Impact on Family Scale (IOF) [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.
Scores for each parent/guardian on The Impact on Family Scale (IOF) [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.
Scores for each parent/guardian on The Impact on Family Scale (IOF) [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.
Scores for each parent/guardian on The Impact on Family Scale (IOF) [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.
Scores for each parent/guardian on The Impact on Family Scale (IOF) [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.
Scores for each parent/guardian on The Impact of Events Scale - Revised [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.
Scores for each parent/guardian on The Impact of Events Scale - Revised [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.
Scores for each parent/guardian on The Impact of Events Scale - Revised [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.
Scores for each parent/guardian on The Impact of Events Scale - Revised [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.
Scores for each parent/guardian on The Impact of Events Scale - Revised [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.
Scores for each parent/guardian on The Impact of Events Scale - Revised [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.
Scores for each parent/guardian on The Post Traumatic Growth Inventory [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.
Scores for each parent/guardian on The Post Traumatic Growth Inventory [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.
Scores for each parent/guardian on The Post Traumatic Growth Inventory [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.
Scores for each parent/guardian on The Post Traumatic Growth Inventory [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.
Scores for each parent/guardian on The Post Traumatic Growth Inventory [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.
Scores for each parent/guardian on The Post Traumatic Growth Inventory [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.
Written responses from each parent/guardian on Open Ended Questions [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.
Written responses from each parent/guardian on Open Ended Questions [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.
Written responses from each parent/guardian on Open Ended Questions [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.
Written responses from each parent/guardian on Open Ended Questions [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.
Written responses from each parent/guardian on Open Ended Questions [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.
Written responses from each parent/guardian on Open Ended Questions [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

Criteria

Ages Eligible for Study:

2 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94158
2	Stanford University	Stanford	California	United States	94304
3	Children's National Medical Center	Washington	District of Columbia	United States	20010
4	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
5	Boston Children's Hospital	Boston	Massachusetts	United States	02115
6	University of Michigan	Ann Arbor	Michigan	United States	48109
7	Duke University	Durham	North Carolina	United States	27705
8	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
9	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104