Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures

2020-03-30 04:42:19 | BioPortfolio


This is a randomized, double-blind, parallel-group, Phase 3 study to evaluate the efficacy of the administration of phenobarbital sodium injection in neonates who have suffered from electrographic or electroclinical seizure. As neonatal seizures can have long-term adverse effects, including death, placebo-controlled studies are not appropriate for this population. This study is designed to show intravenous phenobarbital is effective at preventing subsequent seizures by demonstrating greater efficacy at a higher dose compared to a lower dose.

Study Design


Epilepsy, Benign Neonatal


Phenobarbital Sodium Injection


Not yet recruiting


NEMA Research, Inc.

Results (where available)

View Results


Published on BioPortfolio: 2020-03-30T04:42:19-0400

Clinical Trials [2902 Associated Clinical Trials listed on BioPortfolio]

Study to Evaluate Phenobarbital Sodium Injection for the Treatment of Neonatal Seizures

This is a randomized, double-blind, parallel-group, Phase 3 study to evaluate the efficacy of the administration of phenobarbital Sodium Injection, United States Pharmacopeia, (USP), in pa...

Study of Phenobarbital Inhibition of Catamenial Epilepsy

The purpose of this study is to test the effectiveness of low-dose Phenobarbital on the treatment of catamenial epilepsy. We propose that since the catamenial seizures are associated with...

Prophylactic Phenobarbital After Neonatal Seizures

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 o...

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

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-be...

Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome

The purpose of this study is to compare clonidine versus phenobarbital as adjunctive therapy in those infants who have failed monotherapy with morphine sulfate for neonatal abstinence synd...

PubMed Articles [6930 Associated PubMed Articles listed on BioPortfolio]

The impact of maternal epilepsy on delivery and neonatal outcomes.

Epilepsy is a common neurological disorder that may complicate reproductive health. Our aim in this study was to provide prospective ascertainment of obstetric and neonatal outcomes in women with epil...

Epilepsy occurrence after neonatal morbidities in very preterm infants.

This study investigated the incidence of epilepsy and identified neonatal risk morbidities for epilepsy in children born extremely preterm.

Association between adherence to sodium channel blockers and patient-reported outcomes: Analysis of US survey data among patients with epilepsy.

The objective of this study was to examine the relationship between adherence to treatment with sodium channel blockers (SCBs) and health-related quality of life (HRQoL), work productivity and activit...

Evaluation of sodium valproate loaded nanoparticles in acute and chronic pentylenetetrazole induced seizure models.

Efficacy of sodium valproate in epilepsy is limited by its poor blood brain barrier penetration and side effects. Nanoparticles may offer a better drug delivery system to overcome these limitations. T...

New antiepileptic drugs.

Antiepileptic drugs are the first treatment option in patients with epilepsy. Drugs developed after 2000 are known as third generation antiepileptic drugs. These medications offer new mechanisms of ac...

Medical and Biotech [MESH] Definitions

A condition marked by recurrent seizures that occur during the first 4-6 weeks of life despite an otherwise benign neonatal course. Autosomal dominant familial and sporadic forms have been identified. Seizures generally consist of brief episodes of tonic posturing and other movements, apnea, eye deviations, and blood pressure fluctuations. These tend to remit after the 6th week of life. The risk of developing epilepsy at an older age is moderately increased in the familial form of this disorder. (Neurologia 1996 Feb;11(2):51-5)

A barbiturate that is metabolized to PHENOBARBITAL. It has been used for similar purposes, especially in EPILEPSY, but there is no evidence mephobarbital offers any advantage over PHENOBARBITAL.

An antiepileptic agent related to the barbiturates; it is partly metabolized to PHENOBARBITAL in the body and owes some of its actions to this metabolite. Adverse effects are reported to be more frequent than with PHENOBARBITAL. (From Martindale, The Extra Pharmacopoeia, 30th ed, p309)

A voltage-gated sodium channel subtype that is predominantly expressed in the CENTRAL NERVOUS SYSTEM. Defects in the SCN1A gene which codes for the alpha subunit of this sodium channel are associated with DRAVET SYNDROME, generalized epilepsy with febrile seizures plus, type 2 (GEFS+2), and familial hemiplegic migraine type 3.

A voltage-gated sodium channel subtype that mediates the sodium ion permeability of excitable membranes. Defects in the SCN2A gene which codes for the alpha subunit of this sodium channel are associated with benign familial infantile seizures type 3, and early infantile epileptic encephalopathy type 11.

More From BioPortfolio on "Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures"

Quick Search

Relevant Topics

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

Searches Linking to this Trial