MedTrace Logo

Prophylactic Phenobarbital After Neonatal Seizures

NCT01089504 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2016-02-03

Study results available
· View outcomes & findings →

Summary

The treatment of infants with medications after their seizures have stopped is very variable. No one knows if continuing treatment with phenobarbital for up to several months is helpful or harmful. This clinical trial is designed to help answer that question and provide data that will help determine standard of care for these children.

Conditions

  • Neonatal Seizures

Interventions

DRUG

phenobarbital

Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months

DRUG

placebo

Matched placebo, same volume as active drug, by mouth daily for 4 months

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Ronnie Guillet, MD, PhD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Days
Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01089504 on ClinicalTrials.gov