Clinical trial NCT04337697: Neonatal Seizure Registry - Developmental Functional EValuation
Official title: Neonatal Seizure Registry - Developmental Functional EValuation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Seizure
Hypoxic-Ischemic Encephalopathy
Stroke
Intracranial Hemorrhages
Epilepsy
Cerebral Palsy
Intellectual Disability
Keywords: Family impact
Neurodevelopment
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Stanford University
name: Duke University
name: Boston Children's Hospital
name: Children's National Research Institute
name: Massachusetts General Hospital
name: Children's Hospital of Philadelphia
name: Children's Hospital Medical Center, Cincinnati
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2020-04-08
Enrollment: 188
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient, family members/caregivers, providers, children/minors, subjects unable to read, speak or understand English

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.

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.

Eligibility 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

Primary outcomes:
measure: Full scale IQ (FSIQ) score for each child on the Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI-IV)
timeFrame: At age 5.5 years during in-person study visit
Secondary outcomes:
measure: Change in scores over time for each child on the Vineland Adaptive Behavior Scales, 3rd Edition
timeFrame: At enrollment study visit and annual visits when the child is age 3, 4, 5.5, 7, and 8
Other outcomes:
measure: Scores for each child on Behavior Rating Inventory of Executive Function®, Preschool version (BRIEF-P)
timeFrame: At enrollment study visit
measure: Scores for each child on Behavior Rating Inventory of Executive Function®, Preschool version (BRIEF-P)
timeFrame: At age 5.5 years during in-person study visit
measure: Scores for each child on The Social Responsiveness Scale, 2nd edition (SRS-2) - Parent Form
timeFrame: At enrollment study visit
measure: Scores for each child on The Social Responsiveness Scale, 2nd edition (SRS-2) - Parent Form
timeFrame: At age 5.5 years during in-person study visit
measure: Scores for each child on The Social Responsiveness Scale, 2nd edition (SRS-2) - Teacher Form
timeFrame: At age 5.5 years during in-person study visit
measure: Scores for each child on Behavior Assessment System for Children, 3rd edition (BASC-3) - Parent Form
timeFrame: At enrollment study visit
measure: Scores for each child on Behavior Assessment System for Children, 3rd edition (BASC-3) - Parent Form
timeFrame: At age 5.5 years during in-person study visit
measure: Scores for each child on Behavior Assessment System for Children, 3rd edition (BASC-3) - Teacher Form
timeFrame: At age 5.5 years during in-person study visit
measure: Scores for each child on Child Sensory Profile, 2nd edition - Parent Form
timeFrame: At enrollment study visit
measure: Scores for each child on Child Sensory Profile, 2nd edition - Parent Form
timeFrame: At age 5.5 years during in-person study visit
measure: Scores for each child on Kaufman Test of Educational Achievement, 3rd edition (KTEA-3)
timeFrame: At age 5.5 years during in-person study visit
measure: Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS)
timeFrame: At enrollment study visit
measure: Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS)
timeFrame: At (child) age 3 years during annual study visit
measure: Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS)
timeFrame: At (child) age 4 years during annual study visit
measure: Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS)
timeFrame: At (child) age 5.5 years during in-person study visit
measure: Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS)
timeFrame: At (child) age 7 years during annual study visit
measure: Scores for each parent/guardian on Hospital Anxiety Depression Scale (HADS)
timeFrame: At (child) age 8 years during annual study visit
measure: Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF)
timeFrame: At enrollment study visit
measure: Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF)
timeFrame: At (child) age 3 years during annual study visit
measure: Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF)
timeFrame: At (child) age 4 years during annual study visit
measure: Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF)
timeFrame: At (child) age 5.5 years during in-person study visit
measure: Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF)
timeFrame: At (child) age 7 years during annual study visit
measure: Scores for each parent/guardian on WHO Quality of Life-BREF (WHOQOL-BREF)
timeFrame: At (child) age 8 years during annual study visit
measure: Scores for each parent/guardian on The Impact on Family Scale (IOF)
timeFrame: At enrollment study visit
measure: Scores for each parent/guardian on The Impact on Family Scale (IOF)
timeFrame: At (child) age 3 years during annual study visit
measure: Scores for each parent/guardian on The Impact on Family Scale (IOF)
timeFrame: At (child) age 4 years during annual study visit
measure: Scores for each parent/guardian on The Impact on Family Scale (IOF)
timeFrame: At (child) age 5.5 years during in-person study visit
measure: Scores for each parent/guardian on The Impact on Family Scale (IOF)
timeFrame: At (child) age 7 years during annual study visit
measure: Scores for each parent/guardian on The Impact on Family Scale (IOF)
timeFrame: At (child) age 8 years during annual study visit
measure: Scores for each parent/guardian on The Impact of Events Scale - Revised
timeFrame: At enrollment study visit
measure: Scores for each parent/guardian on The Impact of Events Scale - Revised
timeFrame: At (child) age 3 years during annual study visit
measure: Scores for each parent/guardian on The Impact of Events Scale - Revised
timeFrame: At (child) age 4 years during annual study visit
measure: Scores for each parent/guardian on The Impact of Events Scale - Revised
timeFrame: At (child) age 5.5 years during in-person study visit
measure: Scores for each parent/guardian on The Impact of Events Scale - Revised
timeFrame: At (child) age 7 years during annual study visit
measure: Scores for each parent/guardian on The Impact of Events Scale - Revised
timeFrame: At (child) age 8 years during annual study visit
measure: Scores for each parent/guardian on The Post Traumatic Growth Inventory
timeFrame: At enrollment study visit
measure: Scores for each parent/guardian on The Post Traumatic Growth Inventory
timeFrame: At (child) age 3 years during annual study visit
measure: Scores for each parent/guardian on The Post Traumatic Growth Inventory
timeFrame: At (child) age 4 years during annual study visit
measure: Scores for each parent/guardian on The Post Traumatic Growth Inventory
timeFrame: At (child) age 5.5 years during in-person study visit
measure: Scores for each parent/guardian on The Post Traumatic Growth Inventory
timeFrame: At (child) age 7 years during annual study visit
measure: Scores for each parent/guardian on The Post Traumatic Growth Inventory
timeFrame: At (child) age 8 years during annual study visit
measure: Written responses from each parent/guardian on Open Ended Questions
timeFrame: At enrollment study visit
measure: Written responses from each parent/guardian on Open Ended Questions
timeFrame: At (child) age 3 years during annual study visit
measure: Written responses from each parent/guardian on Open Ended Questions
timeFrame: At (child) age 4 years during annual study visit
measure: Written responses from each parent/guardian on Open Ended Questions
timeFrame: At (child) age 5.5 years during in-person study visit
measure: Written responses from each parent/guardian on Open Ended Questions
timeFrame: At (child) age 7 years during annual study visit
measure: Written responses from each parent/guardian on Open Ended Questions
timeFrame: At (child) age 8 years during annual study visit
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: University of California, San Francisco
name: Hannah C. Glass, MDCM, MAS
role: PRINCIPAL_INVESTIGATOR
References: