Evidence map›Paper›PMID 41565844›Full record

ReviewPediatric research2026

Updated recommendations for the design of therapeutic trials for neonatal seizures.

Janet S Soul, Sonya Wang, Cia Sharpe, Betsy Pilon, Ronit M Pressler, Marilee C Allen, Fahimeda Ali, Stephane Auvin, Christine Barry, Scott Denne and 7 more

Abstract readReview
PubMed Publisher
In one paragraph

Review in Pediatric research, 2026. 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. Article
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

17 authors.

Janet S SoulDepartment of Neurology, Boston Children's Hospital and Harvard Medical School, Boston, MA, USA. Janet.Soul@childrens.harvard.edu.
Sonya WangDepartment of Neurology and Pediatrics, University of Minnesota School of Medicine, Minneapolis, MN, USA.
Cia SharpeDepartment of Paediatric Neurology, Starship Children's Hospital, Auckland, New Zealand.
Betsy PilonHope for HIE, MI, West Bloomfield, USA.
Ronit M PresslerClinical Neuroscience, UCL GOS Institute of Child Health and Department of Clinical Neurophysiology, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.
Marilee C AllenDepartment of Pediatrics, Johns Hopkins School of Medicine, Infant Neurodevelopmental Center, Kennedy Krieger Institute, Baltimore, MD, USA.
Fahimeda AliPaediatric Unit, Innovative Medicines, Healthcare Quality & Access, MHRA, London, UK.
Stephane AuvinPediatric Neurology Department, Reference Center for Rare Epilepsies, Member of ERN Epicare, Hôpital Universitaire Robert Debré, Paris, France.
Christine BarryThe Critical Path Institute, Tucson, AZ, USA.
Scott DenneDepartment of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA.
Hannah C GlassDepartment of Neurology and Weill Institute for Neurosciences, Department of Pediatrics, and Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA.
Agnes V KleinHealth Canada, Toronto, ON, Canada.
Neil MarlowUCL EGA Institute for Women's Health, University College London, London, UK.
Heike RabeDepartment of Academic Paediatrics, Brighton and Sussex Medical School, University of Brighton and University of Sussex, Brighton, UK.
Kanwaljit SinghThe Critical Path Institute, Tucson, AZ, USA.
Collin HovingaThe Critical Path Institute, Tucson, AZ, USA.
International Neonatal Consortium

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The International Neonatal Consortium Seizure Working Group of the Critical Path Institute provides an update to the original recommendations for design of clinical trials to treat neonatal seizures based on recent experiences from several trials and developments in the field. Although there aren't sufficient new data to inform definitions of optimal efficacy endpoints, the Working Group recommended inclusion of alternate measures of seizure burden reduction as secondary or exploratory endpoints, to elucidate clinically meaningful efficacy endpoints for future trials. It was recommended to include additional key covariates, such as timing of seizure onset/cessation, randomization, and ASM administration. There are new recommendations regarding potential for unmasked or single-masked trials, and reporting of concomitant medications and adverse events, and genetic testing. Importantly, specific recommendations were added regarding improved strategies for recruitment and consent, including the use of novel technologies and the involvement of patient advocacy groups. Recommendations regarding trial infrastructure and operational feasibility were included to facilitate trial initiation and conduct, given the many logistical challenges of conducting neonatal seizure treatment trials. Finally, the recommendations consider accommodations for local or national regulations and resources, to ensure that trials are conducted as appropriate to the setting in which the patients are treated. IMPACT: This review provides an update to the initial recommendations for neonatal seizure treatment trial design, with recommendations regarding: (1) exploratory endpoints to inform future trials, (2) additional key covariates to include, (3) considerations regarding masking of investigators, (3) inclusion of concomitant medications and adverse events, (4) genetic testing, (5) strategies for recruitment and consent, and (6) infrastructure and operational feasibility.

Identifiers

PMID41565844

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.