Evidence map›Paper›PMID 30584262›Full record

ArticlePediatric research2019

Recommendations for the design of therapeutic trials for neonatal seizures.

Janet S Soul, Ronit Pressler, Marilee Allen, Geraldine Boylan, Heike Rabe, Ron Portman, Pollyanna Hardy, Sarah Zohar, Klaus Romero, Brian Tseng and 9 more

Open access · hybridAbstract readConsensus Statement
PubMed Full text at PMC Publisher
In one paragraph

Article in Pediatric research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 4 pooled it
9.1field-weighted citation impact, top 2% 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.

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

34 citing papers in PubMed, 4 syntheses or guidelines pooled it, 74 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Anti-seizure medications for neonates with seizures.The Cochrane database of systematic reviews · 2023
    Pooled it
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  12. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 16 institutions in 6 countries.

Janet S SoulBoston Children's Hospital & Harvard Medical School, Boston, MA, USA. Janet.Soul@childrens.harvard.edu.
Ronit PresslerUCL Great Ormond Street Institute of Child Health, London, UK.
Marilee AllenJohns Hopkins, Baltimore, Maryland, USA.
Geraldine BoylanINFANT Research Centre & Department of Paediatrics and Child Health, University College Cork, Cork, Ireland.
Heike RabeBrighton and Sussex Medical School, Brighton, England.
Ron PortmanNovartis Pharma Corp, Cambridge, MA, USA.
Pollyanna HardyUniversity of Birmingham, Birmingham, UK.
Sarah ZoharINSERM, UMRS1138, University Paris V and University Paris VI, Paris, France.
Klaus RomeroCritical Path Institute, Tucson, Arizona, USA.
Brian TsengNovartis Pharma Corp, Cambridge, MA, USA.
Varsha Bhatt-MehtaC.S.Mott Children's Hospital, University of Michigan, Ann Arbor, MI, USA.
Cecil HahnDivision of Neurology, The Hospital for Sick Children and Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.
Scott DenneRiley Children's Hospital, Indiana University, Indianapolis, Indiana, USA.
Stephane AuvinPediatric Neurology Department & INSERM U1141, APHP, Robert Debré University Hospital, Paris, France.
Alexander VinksCollege of Medicine & Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA.
John LantosChildren's Mercy Hospital, Kansas City, Missouri, USA.
Neil MarlowUCL Institute for Women's Health, University College London, London, UK.
Jonathan M DavisThe Floating Hospital for Children at Tufts Medical Center and the Tufts Clinical and Translational Science Institute, Boston, MA, USA.
International Neonatal Consortium
Inserm · FRNovartis (Switzerland) · CHBoston Children's Hospital · USBrighton and Sussex Medical School · GBChildren's Mercy Hospital · USCincinnati Children's Hospital Medical Center · USCritical Path Institute · USGreat Ormond Street Hospital · GBJohns Hopkins University · USLondon Women's Clinic · GBRiley Hospital for Children · USTufts Children's Hospital · USUniversity College Cork · IEUniversity of Birmingham · GBUniversity of Michigan · USUniversity of Toronto · CA

Funding

Critical Path to Public Private PartnershipsU18FD005320 · FDA · CRITICAL PATH INSTITUTE · PI Klaus Romero · 2014 to 2026
$127.1M
FDA HHS U18 FD005320
6 · The paper itself

Abstract

Although seizures have a higher incidence in neonates than any other age group and are associated with significant mortality and neurodevelopmental disability, treatment is largely guided by physician preference and tradition, due to a lack of data from well-designed clinical trials. There is increasing interest in conducting trials of novel drugs to treat neonatal seizures, but the unique characteristics of this disorder and patient population require special consideration with regard to trial design. The Critical Path Institute formed a global working group of experts and key stakeholders from academia, the pharmaceutical industry, regulatory agencies, neonatal nurse associations, and patient advocacy groups to develop consensus recommendations for design of clinical trials to treat neonatal seizures. The broad expertise and perspectives of this group were invaluable in developing recommendations addressing: (1) use of neonate-specific adaptive trial designs, (2) inclusion/exclusion criteria, (3) stratification and randomization, (4) statistical analysis, (5) safety monitoring, and (6) definitions of important outcomes. The guidelines are based on available literature and expert consensus, pharmacokinetic analyses, ethical considerations, and parental concerns. These recommendations will ultimately facilitate development of a Master Protocol and design of efficient and successful drug trials to improve the treatment and outcome for this highly vulnerable population.

Indexed as

Clinical Trials as TopicInfant, Newborn, DiseasesSeizuresHumansInfant, NewbornResearch Design

Identifiers

PMID30584262
PMCPMC6760680
OpenAlexW2906024028

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.