Neonatal SeizureNSR-DEVNCT04337697
Neonatal Seizure Registry - Developmental Functional EValuation
An observational study of Neonatal Seizure and Hypoxic-Ischemic Encephalopathy, run by University of California, San Francisco at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Neonatal Seizure, Hypoxic-Ischemic Encephalopathy, Stroke
- How many people
- 188 participants
- Where
- 9 sitesUnited States
- Study dates
- 15 Mar 2020to 1 Mar 2025
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Outpatient, family members/caregivers, providers, children/minors, subjects unable to read, speak or understand English
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Michigan
Ann Arbor, Michigan, 48109
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Children's Hospital
Boston, Massachusetts, 02115
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Duke University
Durham, North Carolina, 27705
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of California, San Francisco
San Francisco, California, 94158
Stanford University
Stanford, California, 94304
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
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.
Read the 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.
- Conditions
- Neonatal Seizure, Hypoxic-Ischemic Encephalopathy, Stroke, Intracranial Hemorrhages, Epilepsy, Cerebral Palsy
- Keywords
- Family impact, Neurodevelopment
- Medical subject headings
- Hypoxia-Ischemia, Brain, Stroke, Intracranial Hemorrhages, Epilepsy, Cerebral Palsy, Intellectual Disability
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At age 5.5 years during in-person study visit
Secondary outcomes (1)
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.
Measured: At enrollment study visit and annual visits when the child is age 3, 4, 5.5, 7, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start15 Mar 2020
- Primary completion28 Feb 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal SeizureStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 188 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Stanford University, Duke University, Boston Children's Hospital, Children's National Research Institute, Massachusetts General Hospital, Children's Hospital of Philadelphia, Children's Hospital Medical Center, Cincinnati, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Hannah C. Glass, MDCM, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337697
- Sponsor's protocol ID
- 19-28584
- Other IDs
- 1R01NS111166-01A1, R01NS111166
- Acronym
- NSR-DEV
- Status last verified
- Feb 2026
- First submitted
- 31 Mar 2020
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with study sponsor
Publications
Franck LS, Lemmon ME, Grossbauer L, Pawlowski K, Sturza JS, Wusthoff CJ, Massey SL, Chu CJ, Soul JS, Numis AL, Thomas C, Benedetti GM, Anwar T, Berl MM, Gidley Larson JC, Rogers EE, Chen C, McCulloch CE, Glass HC, Shellhaas RA. Parent and Family Well-Being and Associated Risk Factors as Children with Neonatal Seizures Reach Preschool and School-Age: A Longitudinal Cohort Study. J Pediatr Clin Pract. 2025 May 16;16:200149. doi: 10.1016/j.jpedcp.2025.200149. eCollection 2025 Jun.
PubMed 40510235
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Seizure Registry - Developmental Functional EValuation
- ClinicalTrials.gov ID
- NCT04337697
- Acronym / sponsor ID
- NSR-DEV / 19-28584
- Conditions
- Neonatal Seizure, Hypoxic-Ischemic Encephalopathy, Stroke, Intracranial Hemorrhages, Epilepsy, Cerebral Palsy
- Keywords
- Family impact, Neurodevelopment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Michigan, Stanford University, Duke University, Boston Children's Hospital, Children's National Research Institute, Massachusetts General Hospital, Children's Hospital of Philadelphia, Children's Hospital Medical Center, Cincinnati, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Outpatient, family members/caregivers, providers, children/minors, subjects unable to read, speak or understand English
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Derived from this study: PubMed 40510235Franck LS, Lemmon ME, Grossbauer L, Pawlowski K, Sturza JS, Wusthoff CJ, Massey SL, Chu CJ, Soul JS, Numis AL, Thomas C, Benedetti GM, Anwar T, Berl MM, Gidley Larson JC, Rogers EE, Chen C, McCulloch CE, Glass HC, Shellhaas RA. Parent and Family Well-Being and Associated Risk Factors as Children with Neonatal Seizures Reach Preschool and School-Age: A Longitudinal Cohort Study. J Pediatr Clin Pract. 2025 May 16;16:200149. doi: 10.1016/j.jpedcp.2025.200149. eCollection 2025 Jun.
- Individual participant dataSharing planned: Yes. In accordance with study sponsor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah C. Glass, MDCM, MAS principal investigator
University of California, San Francisco
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Seizure and Hypoxic-Ischemic Encephalopathy, run by University of California, San Francisco at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04337697, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.