NCT02789176

Brief Summary

The purpose of this study is to examine whether the duration of treatment with phenobarbital has an impact on neurodevelopmental and epilepsy outcomes, as well as parent and family well-being, after neonatal seizures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2020

Completed
8 months until next milestone

Results Posted

Study results publicly available

November 5, 2020

Completed
Last Updated

December 4, 2020

Status Verified

November 1, 2020

Enrollment Period

3.5 years

First QC Date

May 19, 2016

Results QC Date

October 13, 2020

Last Update Submit

November 20, 2020

Conditions

Neonatal Seizures

Keywords

PhenobarbitalEEGfamily impactneurodevelopment

Outcome Measures

Primary Outcomes (2)

  • WIDEA Neurodevelopmental Outcome Score

    The Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA FS) allowed us to compare the functional development between newborns who received short duration phenobarbital treatment and prolonged phenobarbital treatment. There were 50 questions with response options of 1(Never) to 4(all the time). WIDEA range was on a scale from 50-200 (At 24 months, the normal population mean score is 172±10).The higher the score the better the child's developmental function. Mean scores were calculated using data from any participant who completed surveys at 24 months.

    24 months

  • Number of Participants With Post-neonatal Epilepsy

    The diagnosis of epilepsy and the details of seizure types and frequencies were determined by telephone interview with the parent and corroborated by medical record review.

    24 months

Secondary Outcomes (2)

  • Length of Stay for the Neonatal Seizure Admission

    length of stay, measured in days, will be recorded during a chart review when the child is 12 months of age

  • Impact of Treatment Duration on Parent and Family Well-being

    24 months

Study Arms (2)

Outpatient Enrollees

This is a cohort of 150 subjects who were previously enrolled in the Neonatal Seizure Registry, a multi-center association of institutions across the United States, They were contacted to participate in the study after discharge from the Neonatal Intensive Care Unit (NICU) but prior to the prospective follow up. They were asked to take part in all prospective follow up surveys at 12, 18, \& 24 months of age.

Other: Surveys

NICU Enrollees

This is a cohort of 150 subjects who were enrolled in the study prior to discharge from the NICU. They were asked to complete surveys prior to discharge from the NICU, returned to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, \& completed the follow surveys at 12, 18, \& 24 months of age.

Other: SurveysOther: EEG

Interventions

SurveysOTHER

Regarding development, epilepsy, and family impact

Also known as: Former Neonatal Seizure Registry Subjects
NICU EnrolleesOutpatient Enrollees
EEGOTHER
NICU Enrollees

Eligibility Criteria

Age0 Weeks - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Newborns with seizures who were admitted at one of the participating children's hospitals

You may qualify if:

  • Neonates \<44 weeks corrected age at seizure onset
  • Seizures due to acute brain injury
  • Parent(s) who are English or Spanish literate (with assistance of interpreter)

You may not qualify if:

  • Neonates at risk for adverse outcome independent of seizures and underlying brain injury
  • Neonates with mild, temporary causes for seizures
  • Newborns with neonatal-onset epilepsy syndromes
  • Neonates who do not survive the initial hospital admission
  • Neonates will not be excluded based on race, ethnicity, gender or gestational age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Stanford University

Stanford, California, 94304, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Duke University

Durham, North Carolina, 227710, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Franck LS, Shellhaas RA, Lemmon M, Sturza J, Soul JS, Chang T, Wusthoff CJ, Chu CJ, Massey SL, Abend NS, Thomas C, Rogers EE, McCulloch CE, Grant K, Grossbauer L, Pawlowski K, Glass HC; Neonatal Seizure Registry study group. Associations between Infant and Parent Characteristics and Measures of Family Well-Being in Neonates with Seizures: A Cohort Study. J Pediatr. 2020 Jun;221:64-71.e4. doi: 10.1016/j.jpeds.2020.02.024.

    PMID: 32446494DERIVED

Related Links

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Stephanie Rau
Organization
University of Michigan
shatchew@med.umich.edu
734-232-8474

Study Officials

  • RenĂ©e A Shellhaas, MD, MS

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Hannah C Glass, MDCM, MAS

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 19, 2016

First Posted

June 2, 2016

Study Start

October 1, 2016

Primary Completion

March 24, 2020

Study Completion

March 24, 2020

Last Updated

December 4, 2020

Results First Posted

November 5, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Will be posted on pcori.org

Locations

US(11)