Neonatal Seizure Registry - Developmental Functional EValuation

Stroke Clinical Trial

— NSR-DEV  

Official title:

Neonatal Seizure Registry - Developmental Functional EValuation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04337697
• Other study ID #: 19-28584
• Secondary ID: 1R01NS111166-01A
• Status: Recruiting
• Start date: March 15, 2020
• Est. completion date: February 29, 2024

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: Hannah C. Glass, MDCM, MAS
• Phone: 415-476-3785
• Email: Hannah.glass[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Cerebral Palsy
• Epilepsy
• Hemorrhage
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Intellectual Disability
• Intracranial Hemorrhages
• Neonatal Seizure
• Seizures
• Stroke

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Duke University	Durham	North Carolina
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of California, San Francisco	San Francisco	California
United States	Stanford University	Stanford	California
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (10)

Lead Sponsor	Collaborator
University of California, San Francisco	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Scores for each child on Behavior Rating Inventory of Executive Function®, Preschool version (BRIEF-P)	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.	At enrollment study visit
Other	Scores for each child on Behavior Rating Inventory of Executive Function®, Preschool version (BRIEF-P)	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.	At age 5.5 years during in-person study visit
Other	Scores for each child on The Social Responsiveness Scale, 2nd edition (SRS-2) - Parent Form	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.	At enrollment study visit
Other	Scores for each child on The Social Responsiveness Scale, 2nd edition (SRS-2) - Parent Form	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.	At age 5.5 years during in-person study visit
Other	Scores for each child on The Social Responsiveness Scale, 2nd edition (SRS-2) - Teacher Form	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.	At age 5.5 years during in-person study visit
Other	Scores for each child on Behavior Assessment System for Children, 3rd edition (BASC-3) - Parent Form	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.	At enrollment study visit
Other	Scores for each child on Behavior Assessment System for Children, 3rd edition (BASC-3) - Parent Form	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.	At age 5.5 years during in-person study visit
Other	Scores for each child on Behavior Assessment System for Children, 3rd edition (BASC-3) - Teacher Form	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.	At age 5.5 years during in-person study visit
Other	Scores for each child on Child Sensory Profile, 2nd edition - Parent Form	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.	At enrollment study visit
Other	Scores for each child on Child Sensory Profile, 2nd edition - Parent Form	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.	At age 5.5 years during in-person study visit
Other	Scores for each child on Kaufman Test of Educational Achievement, 3rd edition (KTEA-3)	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.	At age 5.5 years during in-person study visit
Other	Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS)	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.	At enrollment study visit
Other	Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS)	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.	At (child) age 3 years during annual study visit
Other	Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS)	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.	At (child) age 4 years during annual study visit
Other	Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS)	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.	At (child) age 5.5 years during in-person study visit
Other	Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS)	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.	At (child) age 7 years during annual study visit
Other	Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS)	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.	At (child) age 8 years during annual study visit
Other	Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF)	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.	At enrollment study visit
Other	Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF)	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.	At (child) age 3 years during annual study visit
Other	Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF)	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.	At (child) age 4 years during annual study visit
Other	Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF)	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.	At (child) age 5.5 years during in-person study visit
Other	Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF)	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.	At (child) age 7 years during annual study visit
Other	Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF)	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.	At (child) age 8 years during annual study visit
Other	Scores for each parent/guardian on The Impact on Family Scale (IOF)	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.	At enrollment study visit
Other	Scores for each parent/guardian on The Impact on Family Scale (IOF)	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.	At (child) age 3 years during annual study visit
Other	Scores for each parent/guardian on The Impact on Family Scale (IOF)	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.	At (child) age 4 years during annual study visit
Other	Scores for each parent/guardian on The Impact on Family Scale (IOF)	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.	At (child) age 5.5 years during in-person study visit
Other	Scores for each parent/guardian on The Impact on Family Scale (IOF)	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.	At (child) age 7 years during annual study visit
Other	Scores for each parent/guardian on The Impact on Family Scale (IOF)	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.	At (child) age 8 years during annual study visit
Other	Scores for each parent/guardian on The Impact of Events Scale - Revised	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.	At enrollment study visit
Other	Scores for each parent/guardian on The Impact of Events Scale - Revised	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.	At (child) age 3 years during annual study visit
Other	Scores for each parent/guardian on The Impact of Events Scale - Revised	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.	At (child) age 4 years during annual study visit
Other	Scores for each parent/guardian on The Impact of Events Scale - Revised	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.	At (child) age 5.5 years during in-person study visit
Other	Scores for each parent/guardian on The Impact of Events Scale - Revised	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.	At (child) age 7 years during annual study visit
Other	Scores for each parent/guardian on The Impact of Events Scale - Revised	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.	At (child) age 8 years during annual study visit
Other	Scores for each parent/guardian on The Post Traumatic Growth Inventory	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.	At enrollment study visit
Other	Scores for each parent/guardian on The Post Traumatic Growth Inventory	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.	At (child) age 3 years during annual study visit
Other	Scores for each parent/guardian on The Post Traumatic Growth Inventory	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.	At (child) age 4 years during annual study visit
Other	Scores for each parent/guardian on The Post Traumatic Growth Inventory	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.	At (child) age 5.5 years during in-person study visit
Other	Scores for each parent/guardian on The Post Traumatic Growth Inventory	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.	At (child) age 7 years during annual study visit
Other	Scores for each parent/guardian on The Post Traumatic Growth Inventory	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.	At (child) age 8 years during annual study visit
Other	Written responses from each parent/guardian on Open Ended Questions	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.	At enrollment study visit
Other	Written responses from each parent/guardian on Open Ended Questions	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.	At (child) age 3 years during annual study visit
Other	Written responses from each parent/guardian on Open Ended Questions	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.	At (child) age 4 years during annual study visit
Other	Written responses from each parent/guardian on Open Ended Questions	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.	At (child) age 5.5 years during in-person study visit
Other	Written responses from each parent/guardian on Open Ended Questions	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.	At (child) age 7 years during annual study visit
Other	Written responses from each parent/guardian on Open Ended Questions	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.	At (child) age 8 years during annual study visit
Primary	Full scale IQ (FSIQ) score for each child on the Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI-IV)	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.	At age 5.5 years during in-person study visit
Secondary	Change in scores over time for each child on the Vineland Adaptive Behavior Scales, 3rd Edition	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.	At enrollment study visit and annual visits when the child is age 3, 4, 5.5, 7, and 8