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Barbiturate

Phenobarbital Sodium Injection 20mg for Benign Neonatal Epilepsy

Phase 3
Waitlist Available
Led By Taeun Chang, MD
Research Sponsored by NEMA Research, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights

Study Summary

This trial is testing whether phenobarbital can prevent seizures in newborns who have already had one seizure. Because previous seizures can have serious consequences, this trial uses a higher dose of phenobarbital than has been used before to see if it is more effective at preventing seizures.

Eligible Conditions
  • Benign Neonatal Epilepsy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital.
Neonates Who do Not Require Additional Seizure Treatment After the Second Dose of Phenobarbital.
Seizure Burden Over 48 Hours Following Initial Administration of the Phenobarbital Injection.

Trial Design

2Treatment groups
Active Control
Group I: Phenobarbital Sodium Injection 20mgActive Control1 Intervention
Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 20 mg/kg (first/initial dose) followed by 20 mg/kg (if required).
Group II: Phenobarbital Sodium Injection 40mgActive Control1 Intervention
Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 40 mg/kg (first/initial dose) followed by 10 mg/kg (if required).

Find a Location

Who is running the clinical trial?

NEMA Research, Inc.Lead Sponsor
16 Previous Clinical Trials
40,953 Total Patients Enrolled
Taeun Chang, MDPrincipal InvestigatorChildren's National Research Institute
Joseph Pergolizzi Jr., MD, MDPrincipal InvestigatorNEMA Research, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If I volunteer for this research, am I qualified?

"Neonatal epilepsy patients that are between 34 and 44 weeks old may be accepted into this study. A total of 490 participants are needed for the research trial."

Answered by AI

Would this research be able to include individuals above the age of 35?

"The current age bracket for patients being recruited is between 34 and 44 weeks old."

Answered by AI

Are there similar studies to compare this one involving Phenobarbital Sodium Injection 40mg?

"Phenobarbital Sodium Injection 40mg was first studied in 2018 at Tianjin Medical Unversity Second Hospital. Since then, there have been 13 completed clinical trials with 3 active studies as of now. A large quantity of these medical trials are based out of Miami, Florida."

Answered by AI

For what purpose is Phenobarbital Sodium Injection 40mg most often prescribed?

"Phenobarbital Sodium Injection 40mg is most commonly used to help patients manage withdrawal symptoms. However, it can also be given to sedate a patient or prevent febrile seizures."

Answered by AI

Are patients being actively enrolled in this trial at present?

"The study, which began recruiting on March 12th 2021 according to clinicaltrials.gov, is still looking for participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
2021. "Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04320940.
~1 spots leftby Apr 2025
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