- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04337697
Neonatal Seizure Registry - Developmental Functional EValuation (NSR-DEV)
Study Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hannah C. Glass, MDCM, MAS
- Phone Number: 415-476-3785
- Email: Hannah.glass@ucsf.edu
Study Contact Backup
- Name: Yasmeen A. Rezaishad, BS
- Phone Number: 415-476-3785
- Email: yasmeen.rezaishad@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94158
- Recruiting
- University of California, San Francisco
-
Contact:
- Yasmeen A. Rezaishad, BS
- Phone Number: 415-476-3785
- Email: 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
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Sub-Investigator:
- Yi Li, MD
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Stanford, California, United States, 94304
- Recruiting
- Stanford University
-
Contact:
- Sweta Patnaik, MS
- Phone Number: 650-721-1458
- Email: sweta@stanford.edu
-
Principal Investigator:
- Courtney J. Wusthoff, MD
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Recruiting
- Children's National Medical Center
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Contact:
- Courtney Reed Lowe
- Phone Number: 202-476-3807
- Email: clowe@childrensnational.org
-
Principal Investigator:
- Tayyba Anwar, MD
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Recruiting
- Boston Children's Hospital
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Contact:
- Jessica Landers, MS
- Phone Number: 617-355-0578
- Email: jessica.landers@childrens.harvard.edu
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Principal Investigator:
- Janet Soul, MD
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Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Skyler Goodman, BS
- Phone Number: 617-249-4939
- Email: sgoodman8@mgh.harvard.edu
-
Principal Investigator:
- Catherine Chu, MD
-
-
Michigan
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Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
-
Principal Investigator:
- Renee A. Shellhaas, MD, MS
-
Contact:
- Stephanie Rau, BS, CCRP
- Phone Number: 734-232-8474
- Email: shatchew@med.umich.edu
-
Principal Investigator:
- Giulia Benedetti, MD
-
-
North Carolina
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Durham, North Carolina, United States, 27705
- Recruiting
- Duke University
-
Principal Investigator:
- Monica E. Lemmon, MD
-
Contact:
- Jessicka Hamilton
- Phone Number: 919-613-5284
- Email: jessicka.mercer@duke.edu
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Recruiting
- Cincinnati Children's Hospital Medical Center
-
Contact:
- Madeleine Robben
- Phone Number: 513-636-5511
- Email: madeleine.robben@cchmc.org
-
Principal Investigator:
- Cameron Thomas, MD, MS
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Children's Hospital of Philadelphia
-
Contact:
- Darshana Parikh, BA
- Email: parikhd@email.chop.edu
-
Principal Investigator:
- Nicholas Abend, MD, MSCE
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At age 5.5 years during in-person study visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At enrollment study visit and annual visits when the child is age 3, 4, 5.5, 7, and 8
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At enrollment study visit
|
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.
|
At age 5.5 years during in-person study visit
|
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.
|
At enrollment study visit
|
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.
|
At age 5.5 years during in-person study visit
|
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.
|
At age 5.5 years during in-person study visit
|
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.
|
At enrollment study visit
|
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.
|
At age 5.5 years during in-person study visit
|
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.
|
At age 5.5 years during in-person study visit
|
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.
|
At enrollment study visit
|
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.
|
At age 5.5 years during in-person study visit
|
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.
|
At age 5.5 years during in-person study visit
|
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.
|
At enrollment study visit
|
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.
|
At (child) age 3 years during annual study visit
|
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.
|
At (child) age 4 years during annual study visit
|
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.
|
At (child) age 5.5 years during in-person study visit
|
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.
|
At (child) age 7 years during annual study visit
|
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.
|
At (child) age 8 years during annual study visit
|
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.
|
At enrollment study visit
|
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.
|
At (child) age 3 years during annual study visit
|
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.
|
At (child) age 4 years during annual study visit
|
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.
|
At (child) age 5.5 years during in-person study visit
|
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.
|
At (child) age 7 years during annual study visit
|
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.
|
At (child) age 8 years during annual study visit
|
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.
|
At enrollment study visit
|
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.
|
At (child) age 3 years during annual study visit
|
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.
|
At (child) age 4 years during annual study visit
|
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.
|
At (child) age 5.5 years during in-person study visit
|
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.
|
At (child) age 7 years during annual study visit
|
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.
|
At (child) age 8 years during annual study visit
|
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.
|
At enrollment study visit
|
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.
|
At (child) age 3 years during annual study visit
|
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.
|
At (child) age 4 years during annual study visit
|
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.
|
At (child) age 5.5 years during in-person study visit
|
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.
|
At (child) age 7 years during annual study visit
|
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.
|
At (child) age 8 years during annual study visit
|
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.
|
At enrollment study visit
|
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.
|
At (child) age 3 years during annual study visit
|
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.
|
At (child) age 4 years during annual study visit
|
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.
|
At (child) age 5.5 years during in-person study visit
|
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.
|
At (child) age 7 years during annual study visit
|
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.
|
At (child) age 8 years during annual study visit
|
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.
|
At enrollment study visit
|
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.
|
At (child) age 3 years during annual study visit
|
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.
|
At (child) age 4 years during annual study visit
|
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.
|
At (child) age 5.5 years during in-person study visit
|
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.
|
At (child) age 7 years during annual study visit
|
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.
|
At (child) age 8 years during annual study visit
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Hannah C. Glass, MDCM, MAS, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Brain Damage, Chronic
- Signs and Symptoms, Respiratory
- Neurodevelopmental Disorders
- Hypoxia
- Hypoxia, Brain
- Cerebral Palsy
- Brain Ischemia
- Hemorrhage
- Seizures
- Brain Diseases
- Intracranial Hemorrhages
- Intellectual Disability
- Hypoxia-Ischemia, Brain
Other Study ID Numbers
- 19-28584
- 1R01NS111166-01A1 (U.S. NIH Grant/Contract)
- R01NS111166 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
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Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
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IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
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Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
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University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
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University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
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University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
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Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
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University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium