Evidence map›Paper›PMID 41061327›Full record

Trial reportPediatric neurology2025

Neurodevelopmental Outcomes From the PREVeNT Trial.

Sarah E O'Kelley, Jamie K Capal, Tarrant O McPherson, Kristina E Patrick, Deborah A Pearson, Peter E Davis, Kristn Currans, Anna W Byars, Brenda E Porter, Mustafa Sahin and 14 more

Abstract readMulticenter StudyClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pediatric neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

Sarah E O'KelleyDepartments of Psychology and Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama. Electronic address: sokelley@uab.edu.
Jamie K CapalDepartment of Neurology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Division of Neurology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.
Tarrant O McPhersonDepartment of Biostatistics and Bioinformatics, Emory University, Atlanta, Georgia.
Kristina E PatrickDepartment of Neurology, University of Washington School of Medicine, Seattle, Washington; Department of Neurosciences, Seattle Children's Hospital, Seattle, Washington.
Deborah A PearsonLouis A. Faillace, MD Department of Psychiatry and Behavioral Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston (UT Health), Houston, Texas.
Peter E DavisDepartment of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.
Kristn CurransDivision of Behavior Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Anna W ByarsDivision of Neurology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.
Brenda E PorterDepartment of Neurology, Stanford University, Stanford, California.
Mustafa SahinDepartment of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts; Rosamund Stone Zander Translational Neuroscience Center, Boston Children's Hospital, Boston, Massachusetts.
Katherine S TaubDepartment of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Rajsekar RajaramanDepartment of Pediatrics and Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.
Stephanie RandleDepartment of Neurology, University of Washington School of Medicine, Seattle, Washington; Department of Neurosciences, Seattle Children's Hospital, Seattle, Washington.
William M McClintockDivision of Neurology, Department of Pediatrics, Children's National Medical Center, Washington, District of Columbia.
Mary Kay KoenigDepartment of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston (UTHealth Houston), Children's Memorial Hermann Hospital, Houston, Texas.
Michael D FrostMinnesota Epilepsy Group, P.A., Minnesota Epilepsy Group, Roseville, Minnesota.
Klaus WernerDepartment of Pediatrics, Duke University, Durham, North Carolina.
Danielle A NolanPediatric Epilepsy Division, Department of Pediatrics, Corewell Health William Beaumont Children's, Royal Oak, Michigan.
Michael WongDepartment of Neurology, Washington University in Saint Louis, Saint Louis, Missouri.
Jessica L KreftingDepartment of Neurology, University of Alabama at Birmingham, Birmingham, Alabama.
Gary R CutterDepartment of Biostatistics, University of Alabama at Birmingham, Birmingham, Alabama.
Darcy A KruegerDivision of Neurology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.
E Martina BebinDepartments of Neurology and Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama.
PREVeNT Study Group

Funding

Preventing Epilepsy using Vigabatrin in Infants with Tuberous Sclerosis ComplexU01NS092595 · NINDS · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI BEBIN, MARTINA · 2016 to 2020
$7.1M
NINDS NIH HHS U01 NS092595
6 · The paper itself

Abstract

backgroundTuberous Sclerosis Complex (TSC) is associated with high prevalence of epilepsy, intellectual and developmental disability, and autism spectrum disorder (ASD). PREVeNT, a Phase IIb, multicenter, double-blind placebo-controlled trial, evaluated the efficacy of vigabatrin in preventing intellectual and developmental disability and ASD in infants with TSC. Phenotypic, developmental, and ASD-specific outcomes at 36 months are presented.

methodsEighty-four infants with TSC were enrolled in PREVeNT across 13 TSC clinics in the United States. Participants underwent neurodevelopmental assessments at ages 6 months through 36 months. Clinical best estimate diagnosis of ASD or non-ASD along with a rating of clinical certainty was determined at 36 months.

resultsSixty-five participants completed assessments through 36 months of age. Mean cognitive scores on the Bayley-III were in the low average range at 12 months. Cognitive scores declined slightly in all groups over time. Adaptive scores were in the low average range for the seizure groups. For all neurocognitive measures, those in the watchful waiting group exhibited higher scores compared to the other cohorts. Language scores became more commensurate with cognitive scores by 36 months. The Clinical Certainty Rating was available for 58 patients, with 31% rated as having ASD; this did not differ by treatment assignment.

conclusionsNo significant differences in developmental or autism-specific outcomes were seen between treatment groups, and no participants without epilepsy were diagnosed with ASD. This may be due to early detection of seizures, closer developmental monitoring and follow-up in the trial, and impacts of the pandemic on study participation.

Indexed as

AnticonvulsantsAutism Spectrum DisorderDevelopmental DisabilitiesIntellectual DisabilityTuberous SclerosisVigabatrinChild, PreschoolDouble-Blind MethodFemaleHumansInfantMaleTreatment OutcomeAnticonvulsantsVigabatrinAutismDevelopmentTuberous sclerosis complexVigabatrin

Identifiers

PMID41061327
PMCPMC12554379

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.