Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study

Neonatal Seizures Clinical Trial

Official title:

Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02789176
• Other study ID #: HUM00114541
• Secondary ID: 1507-31187
• Status: Completed
• Start date: October 2016
• Est. completion date: March 24, 2020

Study information

• Verified date: November 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: March 24, 2020
• Est. primary completion date: March 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Neonatal Seizures
• Seizures

Intervention

Other:
• Surveys
Regarding development, epilepsy, and family impact
• EEG

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Brigham and Women'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 (12)

Lead Sponsor	Collaborator
University of Michigan	Beth Israel Deaconess Medical Center, Boston Children's Hospital, Brigham and Women's Hospital, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Children's National Research Institute, Duke University, Massachusetts General Hospital, Patient-Centered Outcomes Research Institute, Stanford University, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Length of Stay for the Neonatal Seizure Admission	Evaluation of medication exposure (dose and duration) during the admission as a predictor of the number of days the infant requires care (length of stay)	length of stay, measured in days, will be recorded during a chart review when the child is 12 months of age
Secondary	Impact of Treatment Duration on Parent and Family Well-being	Surveys selected with the help of our Parent Partners were given at 12, 18, and 24 months to assess the impact of neonatal seizure treatment duration on parent and family quality of life and well-being. The 24 month data is presented, as they align with the primary outcome. The study team reviewed the HADS 24 month Anxiety and Depression Score range of possible scores from 0-21 (higher = more depressed/more anxious), the 24 month Transformed WHO Overall Quality of Life and General Health score range of scores 0-100 (higher=better quality of life), the 24 month Impact on Family Scale overall impact scale range from 15-60 (higher = more impact on family), the 24 month Post Traumatic Growth Inventory scale range from 0 -105 (higher = better/more growth), and the 24 month Impact of Events Scale-Revised scale range from 0 - 88 (higher score = worse impact).	24 months

External Links

•   PCORI website