دورية أكاديمية
Protocol for a magnetic resonance imaging study of participants in the fever RCT: Does fever control prevent brain injury in malaria?
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.) |
References: | Am J Trop Med Hyg. 1991 Feb;44(2):168-75. (PMID: 2012260) Trans R Soc Trop Med Hyg. 1990;84 Suppl 2:1-65. (PMID: 2219249) QJM. 1996 Aug;89(8):591-7. (PMID: 8935480) Trop Med Int Health. 2005 Jan;10(1):3-10. (PMID: 15655008) Wellcome Open Res. 2018 Nov 1;3:141. (PMID: 30662959) Pediatrics. 2019 Feb;143(2):. (PMID: 30696757) Am J Trop Med Hyg. 2017 Jul;97(1):225-231. (PMID: 28719298) World J Crit Care Med. 2012 Aug 04;1(4):106-22. (PMID: 24701408) Front Neurol. 2023 Jul 10;14:1168836. (PMID: 37492851) Clin Perinatol. 2002 Dec;29(4):623-49, vi. (PMID: 12516739) Pediatrics. 2008 Jul;122(1):e92-9. (PMID: 18541616) Epilepsy Behav. 2008 Nov;13(4):620-3. (PMID: 18602496) Arch Dis Child Fetal Neonatal Ed. 2012 Jul;97(4):F267-72. (PMID: 22215799) PLoS Med. 2010 May 25;7(5):e1000273. (PMID: 20520849) Brain Pathol. 2000 Jan;10(1):145-52. (PMID: 10668904) Nat Med. 2004 Feb;10(2):143-5. (PMID: 14745442) Stat Med. 1998 Oct 15;17(19):2265-81. (PMID: 9802183) Lancet Neurol. 2005 Dec;4(12):827-40. (PMID: 16297841) J Neurol Neurosurg Psychiatry. 2005 Apr;76(4):476-81. (PMID: 15774431) Dev Med Child Neurol. 2006 Jan;48(1):51-7. (PMID: 16359594) Lancet. 2010 Nov 13;376(9753):1647-57. (PMID: 21062666) Stroke. 2008 Nov;39(11):3029-35. (PMID: 18723420) Neurology. 2013 Aug 6;81(6):585-8. (PMID: 23918861) BMC Pediatr. 2007 Sep 05;7:30. (PMID: 17784966) Clin Pharmacol Ther. 2008 Jul;84(1):52-62. (PMID: 17971810) Semin Fetal Neonatal Med. 2006 Oct;11(5):363-8. (PMID: 16581321) J Perinatol. 2006 Mar;26(3):180-4. (PMID: 16407967) Brain. 1992 Jun;115 ( Pt 3):783-94. (PMID: 1628202) Lancet Neurol. 2010 Dec;9(12):1173-1181. (PMID: 21056005) Neurocrit Care. 2011 Sep;15(2):287-94. (PMID: 21755388) BMC Med. 2019 May 21;17(1):98. (PMID: 31109328) J Neurosurg Anesthesiol. 2006 Jan;18(1):5-10. (PMID: 16369134) PLoS One. 2022 Oct 7;17(10):e0268414. (PMID: 36206262) Acta Paediatr. 2015 Feb;104(2):138-45. (PMID: 25164710) Neuroradiol J. 2009 Aug 29;22(4):407-12. (PMID: 24207146) Epilepsia. 2004 Aug;45(8):978-81. (PMID: 15270766) Psychol Assess. 2023 Apr;35(4):366-377. (PMID: 36633980) Anesth Analg. 2010 Apr 1;110(4):1239. (PMID: 20357161) Surg Neurol Int. 2018 Mar 01;9:53. (PMID: 29576904) Malar J. 2011 Jun 01;10:148. (PMID: 21631932) Nat Rev Neurol. 2012 Feb 28;8(4):214-22. (PMID: 22371279) Psychopharmacol Bull. 1985;21(4):773-800. (PMID: 4089106) J Infect Dis. 2014 Feb 15;209(4):610-5. (PMID: 24048963) AJNR Am J Neuroradiol. 2012 Oct;33(9):1740-6. (PMID: 22517285) Br J Radiol. 2011 Apr;84(1000):380-5. (PMID: 21415303) |
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 |
تدمد: | 1932-6203 |
---|---|
DOI: | 10.1371/journal.pone.0294823 |