Evidence map›Paper›PMID 38640099›Full record

ArticlePloS one2024

Protocol for a magnetic resonance imaging study of participants in the fever RCT: Does fever control prevent brain injury in malaria?

Moses B Chilombe, Karl B Seydel, Colleen A Hammond, Suzanna Mwanza, Archana A Patel, Frank Lungu, Somwe Wa Somwe, Sam Kampondeni, Michael J Potchen, Michael P McDermott and 1 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 92% 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

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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

11 authors at 6 institutions in 2 countries.

Moses B ChilombeBlantyre Malaria Project, Kamuzu University of Health Sciences, Blantyre, Malawi.ORCID 0000-0002-0948-2670
Karl B SeydelBlantyre Malaria Project, Kamuzu University of Health Sciences, Blantyre, Malawi.
Colleen A HammondDepartment of Radiology, Michigan State University, East Lansing, Michigan, United States of America.
Suzanna MwanzaDepartment of Pediatrics and Child Health, Chipata Central Hospital, Chipata, Zambia.ORCID 0000-0001-8080-7215
Archana A PatelDepartment of Neurology, Boston Children's Hospital, Boston, Massachusetts, United States of America.ORCID 0000-0002-1159-0128
Frank LunguNeurology Research Office, University Teaching Hospitals Children's Hospital, Lusaka, Zambia.
Somwe Wa SomweNeurology Research Office, University Teaching Hospitals Children's Hospital, Lusaka, Zambia.ORCID 0000-0001-7217-4382
Sam KampondeniMpingwe Clinic, Limbe, Malawi.
Michael J PotchenDepartment of Imaging Sciences, University of Rochester, Rochester, New York, United States of America.
Michael P McDermottDepartment of Biostatistics and Computational Biology, University of Rochester, Rochester, New York, United States of America.
Gretchen L BirbeckNeurology Research Office, University Teaching Hospitals Children's Hospital, Lusaka, Zambia.ORCID 0000-0002-0735-3461
University Teaching Hospital · ZMMichigan United · USUniversity of Rochester · USBoston Children's Hospital · USKamuzu University of Health SciencesUniversity of Zambia · ZM

Funding

Global Research Endeavors to Advance Treatment of Neurological Disorders in Africa (GREAT Neurology)R35NS122265 · NINDS · UNIVERSITY OF ROCHESTER · PI GRETCHEN L. BIRBECK · 2021 to 2026
$3.1M
An MRI Ancillary Study of Malaria Fever Control RCTR01NS111057 · NINDS · UNIVERSITY OF ROCHESTER · PI BIRBECK, GRETCHEN L., POTCHEN, MICHAEL JAMES · 2020 to 2024
$1.3M
Predicting Epilepsy in Cerebral Malaria: Working Toward Identifying Biomarkers of Epileptogenesis in ChildrenK23NS118051 · NINDS · SEATTLE CHILDREN'S HOSPITAL · PI PATEL, ARCHANA A. · 2021 to 2025
$1.1M
NINDS NIH HHS K23 NS118051NINDS NIH HHS R01 NS111057NINDS NIH HHS R35 NS122265
6 · The paper itself

Abstract

backgroundDespite eradication efforts, ~135,000 African children sustained brain injuries as a result of central nervous system (CNS) malaria in 2021. Newer antimalarial medications rapidly clear peripheral parasitemia and improve survival, but mortality remains high with no associated decline in post-malaria neurologic injury. A randomized controlled trial of aggressive antipyretic therapy with acetaminophen and ibuprofen (Fever RCT) for malarial fevers being conducted in Malawi and Zambia began enrollment in 2019. We propose to use neuroimaging in the context of the RCT to further evaluate neuroprotective effects of aggressive antipyretic therapy.

methodsThis observational magnetic resonance imaging (MRI) ancillary study will obtain neuroimaging and neurodevelopmental and behavioral outcomes in children previously enrolled in the Fever RCT at 1- and 12-months post discharge. Analysis will compare the odds of any brain injury between the aggressive antipyretic therapy and usual care groups based upon MRI structural abnormalities. For children unable to undergo imaging without deep sedation, neurodevelopmental and behavioral outcomes will be used to identify brain injury. DISCUSSION: Neuroimaging is a well-established, valid proxy for neurological outcomes after brain injury in pediatric CNS malaria. This MRI ancillary study will add value to the Fever RCT by determining if treatment with aggressive antipyretic therapy is neuroprotective in CNS malaria. It may also help elucidate the underlying mechanism(s) of neuroprotection and expand upon FEVER RCT safety assessments.

Indexed as

AntipyreticsBrain InjuriesMalariaAftercareChildFeverHumansMagnetic Resonance ImagingObservational Studies as TopicPatient DischargeRandomized Controlled Trials as TopicAntipyretics

Identifiers

PMID38640099
PMCPMC11029645
OpenAlexW4394951924

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.