دورية أكاديمية
أعرض في EDS

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

التفاصيل البيبلوغرافية
العنوان: Protocol for a magnetic resonance imaging study of participants in the fever RCT: Does fever control prevent brain injury in malaria?
المؤلفون: Chilombe MB; Blantyre Malaria Project, Kamuzu University of Health Sciences, Blantyre, Malawi., Seydel KB; Blantyre Malaria Project, Kamuzu University of Health Sciences, Blantyre, Malawi.; Department of Osteopathic Medical Specialties, Michigan State University, East Lansing, Michigan, United States of America., Hammond CA; Department of Radiology, Michigan State University, East Lansing, Michigan, United States of America., Mwanza S; Department of Pediatrics and Child Health, Chipata Central Hospital, Chipata, Zambia., Patel AA; Department of Neurology, Boston Children's Hospital, Boston, Massachusetts, United States of America., Lungu F; Neurology Research Office, University Teaching Hospitals Children's Hospital, Lusaka, Zambia., Wa Somwe S; Neurology Research Office, University Teaching Hospitals Children's Hospital, Lusaka, Zambia., Kampondeni S; Mpingwe Clinic, Limbe, Malawi.; Department of Imaging Sciences, University of Rochester, Rochester, New York, United States of America., Potchen MJ; Department of Imaging Sciences, University of Rochester, Rochester, New York, United States of America.; Zambia College of Medicine and Surgery, Lusaka, Zambia., McDermott MP; Department of Biostatistics and Computational Biology, University of Rochester, Rochester, New York, United States of America.; Department of Neurology, University of Rochester, Rochester, New York, United States of America., Birbeck GL; Neurology Research Office, University Teaching Hospitals Children's Hospital, Lusaka, Zambia.; Department of Neurology, University of Rochester, Rochester, New York, United States of America.
المصدر: PloS one [PLoS One] 2024 Apr 19; Vol. 19 (4), pp. e0294823. Date of Electronic Publication: 2024 Apr 19 (Print Publication: 2024).
نوع المنشور: Clinical Trial Protocol; Journal Article
اللغة: English
بيانات الدورية: Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE
أسماء مطبوعة: Original Publication: San Francisco, CA : Public Library of Science
مواضيع طبية MeSH: Antipyretics*/therapeutic use , Malaria* , Brain Injuries*, Humans ; Child ; Aftercare ; Patient Discharge ; Fever/complications ; Fever/drug therapy ; Fever/prevention & control ; Magnetic Resonance Imaging ; Randomized Controlled Trials as Topic ; Observational Studies as Topic
مستخلص: Background: Despite 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.
Methods: This 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.
Competing Interests: Moses Chilombe has no disclosures. Karl B. Seydel has received funding from the US NIH. Colleen Hammond has no disclosures. Suzanna Mwanza has not disclosures. Archana Patel -has received funding from the US NIH. . Frank Lungu has no disclosures. Somwe wa Somwe has no disclosures. Sam Kampondeni has no disclosures. Michael J. Potchen has received funding. from the US NIH and is a paid medical legal consultant on work unrelated to the research presented here. Gretchen L. Birbeck has received funding from the US NIH and is a paid consultant for BlueSpark Technologies.
(Copyright: © 2024 Chilombe et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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معلومات مُعتمدة: K23 NS118051 United States NS NINDS NIH HHS
المشرفين على المادة: 0 (Antipyretics)
تواريخ الأحداث: Date Created: 20240419 Date Completed: 20240422 Latest Revision: 20240502
رمز التحديث: 20240502
مُعرف محوري في PubMed: PMC11029645
DOI: 10.1371/journal.pone.0294823
PMID: 38640099
قاعدة البيانات: MEDLINE
الوصف
تدمد:1932-6203
DOI:10.1371/journal.pone.0294823