Evidence map›Paper›PMID 32385134›Full record

Trial reportPediatrics2020

Levetiracetam Versus Phenobarbital for Neonatal Seizures: A Randomized Controlled Trial.

Cynthia Sharpe, Gail E Reiner, Suzanne L Davis, Mark Nespeca, Jeffrey J Gold, Maynard Rasmussen, Rachel Kuperman, Mary Jo Harbert, David Michelson, Priscilla Joe and 16 more

Erratum issued 3 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pediatrics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 84 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
84citing papers in PubMed, 8 pooled it
38.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04926844 phase2completednot on this mapstarted 2021, after this paper: background citation

Effectiveness of Combined Levetiracetam and Midazolam in Treatment of Generalized Convulsive Status Epilepticus in Children

TypeinterventionalSponsorSohag UniversityRan2021 to 2022Enrolled144ConditionsStatus Epilepticus, Generalized Convulsive Status Epilepticus, Status Epilepticus, Generalized, Status Epilepticus, Generalized ConvulsiveArmsLevetiracetam, Midazolam, Placebo
NCT07284498 phase4not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Treatment of Seizures in Neonate With Hypoxic Ischemic Encephalopathy

TypeinterventionalSponsorMansoura UniversityRan2026 to 2026Enrolled66ConditionsNeonatal Seizures, HIE - Hypoxic - Ischemic EncephalopathyArmsPhenobarbital, Levetiracetam
NCT07401433 nacompletednot on this mapstarted 2024, after this paper: background citation

Efficacy Of Levetiracetam in the Treatment of Neonatal Seizures Presenting at Tertiary Care Hospital.

TypeinterventionalSponsorHayat Abad Medical Complex, PeshawarRan2024 to 2025Enrolled260ConditionsNeonatal SeizuresArmsLevetiracetam, Phenobarbital Sodium Injection
3 · Its place in the literature

Who cites it

84 citing papers in PubMed, 8 syntheses or guidelines pooled it, 197 citations in OpenAlex.

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  5. Anti-seizure medications for neonates with seizures.The Cochrane database of systematic reviews · 2023
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24 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 9 institutions in 2 countries.

Cynthia SharpeDepartment of Paediatric Neurology, Starship Children's Health, Auckland, New Zealand.
Gail E ReinerDepartment of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.
Suzanne L DavisDepartment of Paediatric Neurology, Starship Children's Health, Auckland, New Zealand.
Mark NespecaDepartment of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.
Jeffrey J GoldDepartment of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.
Maynard RasmussenSan Diego Neonatology Inc and.
Rachel KupermanPediatric Neurology, University of California, San Francisco Benioff Children's Hospital Oakland, Oakland, California.
Mary Jo HarbertDepartment of Neurosciences, School of Medicine, University of California, San Diego and Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.
David MichelsonDivision of Pediatric Neurology, Department of Pediatrics, Loma Linda University Children's Hospital, Loma Linda, California.
Priscilla JoeDivision of Neonatology, Departments of Pediatrics and.
Sonya WangDepartment of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.
Neggy RismanchiDepartment of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.
Ngoc Minh LeNeonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.
Andrew MowerDepartment of Neurology, Children's Hospital of Orange County, Orange, California.
Jae KimDivision of NeoNatology, Departments of Pediatrics and.
Malcolm R BattinDepartment of Neonatology, Auckland District Health Board, Auckland, New Zealand; and.
Brian LaneDivision of Neonatology, Departments of Pediatrics, University of California, San Diego and Rady Children's Hospital San Diego, San Diego, California.
Jose HonoldDivision of Neonatology, Departments of Pediatrics, University of California, San Diego and Rady Children's Hospital San Diego, San Diego, California.
Ellen KnodelDivision of Neonatology, Departments of Pediatrics, University of California, San Diego and Rady Children's Hospital San Diego, San Diego, California.
Kathy ArnellNeonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.
Renee BridgeDivision of NeoNatology, Departments of Pediatrics and.
Lilly LeeNeurosciences, School of Medicine, University of California, San Diego, San Diego, California.
Karin ErnstromAlzheimer's Therapeutic Research Institute, Keck School of Medicine, University of Southern California, Los Angeles, California.
Rema RamanAlzheimer's Therapeutic Research Institute, Keck School of Medicine, University of Southern California, Los Angeles, California.
Richard H HaasDepartment of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California; rhaas@health.ucsd.edu.
NEOLEV2 INVESTIGATORS
University of California, San Diego · USRady Children's Hospital-San Diego · USSharp Mary Birch Hospital for Women & Newborns · USUniversity of Southern California · USAuckland District Health Board · NZChildren's Hospital of Orange County · USLoma Linda University Children's Hospital · USStarship Children's Health · NZUCSF Benioff Children's Hospital · US

Funding

UC San Diego Clinical and Translational Research InstituteUL1TR001442 · NCATS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI FIRESTEIN, GARY S, HOGARTH, MICHAEL · 2015 to 2024
$88.3M
Phase 2 Study of Levetiracetam for Neonatal SeizuresR01FD004147 · FDA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI HAAS, RICHARD H · 2012 to 2016
$1.6M
FDA HHS R01 FD004147NCATS NIH HHS UL1 TR001442
6 · The paper itself

Abstract

BACKGROUND AND

objectivesThere are no US Food and Drug Administration-approved therapies for neonatal seizures. Phenobarbital and phenytoin frequently fail to control seizures. There are concerns about the safety of seizure medications in the developing brain. Levetiracetam has proven efficacy and an excellent safety profile in older patients; therefore, there is great interest in its use in neonates. However, randomized studies have not been performed. Our objectives were to study the efficacy and safety of levetiracetam compared with phenobarbital as a first-line treatment of neonatal seizures.

methodsThe study was a multicenter, randomized, blinded, controlled, phase IIb trial investigating the efficacy and safety of levetiracetam compared with phenobarbital as a first-line treatment for neonatal seizures of any cause. The primary outcome measure was complete seizure freedom for 24 hours, assessed by independent review of the EEGs by 2 neurophysiologists.

resultsEighty percent of patients (24 of 30) randomly assigned to phenobarbital remained seizure free for 24 hours, compared with 28% of patients (15 of 53) randomly assigned to levetiracetam (

conclusionsIn this phase IIb study, phenobarbital was more effective than levetiracetam for the treatment of neonatal seizures. Higher rates of adverse effects were seen with phenobarbital treatment. Higher-dose studies of levetiracetam are warranted, and definitive studies with long-term outcome measures are needed.

Indexed as

AnticonvulsantsDose-Response Relationship, DrugDouble-Blind MethodEpilepsy, Benign NeonatalFemaleHumansInfant, NewbornLevetiracetamMalePhenobarbitalSeizuresAnticonvulsantsLevetiracetamPhenobarbital

Identifiers

PMID32385134
PMCPMC7263056
OpenAlexW3021808607

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.