Brain InjuriesMRIANCT05746819
An MRI Ancillary Study of a Malaria Fever Investigation
An observational study of Brain Injuries and Malaria, run by University of Rochester at 2 sites in 2 countries.
Trial summary
This study will seek consent from parents of children enrolled in the Malaria FEVER study to obtain neuroimaging and 12-month neuropsychiatric outcomes data and kidney function on their child. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Brain Injuries, Malaria, MRI Imaging
- How many people
- 181 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 2 Jan 2021to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: All children enrolled in the Malaria RCT who survive to discharge are eligible for enrollment.
Who may be able to join
- All children enrolled in the parent Malaria RCT study are eligible
- Signed parental consent is required
- CNS symptoms associated with malaria.
Who cannot join
- Circulatory failure (cold extremities, capillary refill > 3 seconds, sunken eyes, ↓ skin turgor)
- Vomiting in the past 2 hours
- Serum Cr > 1.2 mg/dL
- A history of liver disease
- Jaundice or a total bilirubin of >3.0mg/dL
- A history of gastric ulcers or gastrointestinal bleeding
Show all 10Show fewer
- A history of thrombocytopenia or other primary hematologic disorder
- Petechiae or other clinical indications of bleeding abnormalities
- A known allergy to ibuprofen, acetaminophen, aspirin or any non-steroidal medication
- Any contraindication for nasogastric tube (NGT) placement and/or delivery of enteral medications
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An MRI Ancillary Study of a Malaria Fever Randomized Controlled Trial (RCT)
This study will seek consent from parents of children enrolled in the Malaria FEVER study to obtain neuroimaging and 12-month neuropsychiatric outcomes data and kidney function on their child. The imaging and evaluations for this observational study will occur after the child has recovered from the acute malaria infection and has otherwise completed the RCT intervention and safety evaluations.
Read the detailed description
Despite eradication efforts, ~400,000 African children sustained brain injuries as a result of CNS malaria in 2016. A higher maximum temperature (Tmax) during the acute malaria infection is an established risk factor for neurologic sequelae and a randomized controlled trial (RCT) of aggressive antipyretic therapy with acetaminophen and ibuprofen conducted in Malawi and Zambia began enrollment in 2019 (R01NS102176). In that clinical trial, the primary outcome was Tmax during the acute infection. However, the antipyretic therapies used in this RCT may offer neuroprotective effects without affecting Tmax--for example, neuroprotection through anti-inflammatory mechanisms. In An MRI Ancillary Study of Malaria FEVER RCT, we propose to use neuroimaging in the context of the RCT to further evaluate the potential neuroprotective effects of aggressive antipyretic therapy for CNS malaria and explore possible mechanisms for these effects. Comparing children allocated to aggressive antipyretic therapy vs. usual care on the prevalence of structural brain abnormalities after recovery from CNS malaria will facilitate the evaluation of non-fever pathways for neuroprotection. Brain MRIs will be obtained in children enrolled in the RCT at 1- and 12-months post recovery. Analyses will be completed comparing the odds of having any structural injury based upon RCT treatment allocation and based upon (Tmax) stratified by treatment allocation to assess changes specifically related to response to therapy in terms of fever reduction. Potential mechanisms of aggressive antipyretic-related injury will be evaluated including assessments for treatment-related CNS bleeds. Neuroimaging is a well-established, valid proxy for neurological outcomes after brain injury including in pediatric CNS malaria. Adding this MRI ancillary study to our fever RCT may elucidate mechanisms of treatment-associated injury and allow for early identification of neuroprotection from aggressive antipyretic use that would otherwise require long-term follow-up for cognitive and behavioral assessments. This study will provide critical insights that could inform future neuroprotective studies of malaria that might incorporate imaging to optimize study design. It will also add to our understanding of the long term impact of severe malaria on chronic kidney disease risk in children.
- Conditions
- Brain Injuries, Malaria, MRI Imaging, Neurocognitive Deficits, Chronic Kidney Diseases, Behavior Problem
- Being tested
- Aggressive antipyretics therapy of fever vs usual care in the Malaria RCT study
- Medical subject headings
- Brain Injuries, Malaria, Renal Insufficiency, Chronic, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aggressive antipyretics therapy of fever vs usual care in the Malaria RCT studyOther
Also called NCT03399318
After clinical trial of the Malaria RCT study, this study will compare children allocated to aggressive antipyretic therapy vs. usual care on the prevalence of structural brain abnormalities after recovery from CNS malaria.
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI neuroimaging 1a
Children in the RCT will undergo brain MRIs at 1 month after their acute malaria illness to check for any structural injury following CNS malaria. Two radiologists, blinded to treatment allocation, will independently review images and identify the presence or absence of any injury (present vs absent) For children who are unable to tolerate imaging, brain injury status will be determined by outcomes from age-specific neurocognitive and behavioral assessments.
Measured: at 1 month
MRI neuroimaging 1a
Children in the RCT will undergo brain MRIs at 12 months after their acute malaria illness to check for any structural injury following CNS malaria. Two radiologists, blinded to treatment allocation, will independently review images and identify the presence or absence of any injury (present vs absent) For children who are unable to tolerate imaging, brain injury status will be determined by outcomes from age-specific neurocognitive and behavioral assessments.
Measured: at 12 months
Secondary outcomes (14)
Comparing specific abnormalities in the two groups by allocation: Brain atrophy
The Potchen volume score is 1-3 abnormal due to atrophy, 4-5 normal, 6-8 edema. And these are analyzed as three ordinal categories--atrophic, normal or edematous
Measured: at 1 month post recovery
Comparing specific abnormalities in the two groups by allocation: Brain atrophy
The Potchen volume score is 1-3 abnormal due to atrophy, 4-5 normal, 6-8 edema. And these are analyzed as three ordinal categories--atrophic, normal or edematous
Measured: at 12 months post recovery
Comparing specific abnormalities in the two groups by allocation: Gliosis by Fazekas score
Gliosis by Fazekas score, which assesses white matter lesions on brain MRI scans. The scoring is from 0-3, with 0 = no lesion, 1 = mild, 2 = moderate and 3 = severe.
Measured: 1 month post recovery
Comparing specific abnormalities in the two groups by allocation: Gliosis by Fazekas score
Gliosis by Fazekas score, which assesses white matter lesions on brain MRI scans. The scoring is from 0-3, with 0 = no lesion, 1 = mild, 2 = moderate and 3 = severe.
Measured: 12 month post recovery
Comparing specific abnormalities in the two groups by allocation:The presence or absence of regional gliosis or atrophy in cortical region
Comparing specific abnormalities in the two groups by allocation:The presence of regional gliosis or atrophy in cortical region
Measured: at 1 month post recovery
Comparing specific abnormalities in the two groups by allocation:The presence or absence of regional gliosis or atrophy in cortical region
Comparing specific abnormalities in the two groups by allocation:The presence of regional gliosis or atrophy in cortical region
Measured: at 12 month post recovery
Comparing specific abnormalities in the two groups by allocation:The presence or absence of regional gliosis or atrophy in deep gray
Comparing specific abnormalities in the two groups by allocation:The presence of regional gliosis or atrophy in deep gray
Measured: 1 month post recovery
Comparing specific abnormalities in the two groups by allocation:The presence or absence of regional gliosis or atrophy in deep gray
Comparing specific abnormalities in the two groups by allocation:The presence or absence of regional gliosis or atrophy in deep gray
Measured: 12 months post recovery
Comparing specific abnormalities in the two groups by allocation:The presence or absence of regional gliosis or atrophy in corpus callosum
Comparing specific abnormalities in the two groups by allocation:The presence of regional gliosis or atrophy in corpus callosum
Measured: 1 month post recovery
Comparing specific abnormalities in the two groups by allocation:The presence of or absence regional gliosis or atrophy in corpus callosum
Comparing specific abnormalities in the two groups by allocation:The presence of regional gliosis or atrophy in corpus callosum
Measured: 12 months post recovery
Comparing specific abnormalities in the two groups by allocation:The presence or absence of regional gliosis or atrophy in posterior fossa
Comparing specific abnormalities in the two groups by allocation:The presence of regional gliosis or atrophy in posterior fossa
Measured: 1 month post recovery
Comparing specific abnormalities in the two groups by allocation:The presence or absence of regional gliosis or atrophy in posterior fossa
Comparing specific abnormalities in the two groups by allocation:The presence or absence of regional gliosis or atrophy in posterior fossa
Measured: at 12 months post recovery
Safety assessment: bleeding
Where GRE imaging is available, we will compare presence/absence of evidence of GRE positive findings
Measured: at 1-month
Safety assessment: kidney
Compare incident chronic kidney disease based upon urine albumin:creatinine ratio with a cut off of ACR of 3
Measured: At least 6 months post malaria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start2 Jan 2021
- Primary completion31 Aug 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (68)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gretchen Birbeck, University of Rochester
- Investigators
- Karl B Seydel, PhD, Principal investigator, Michigan State University, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746819
- Sponsor's protocol ID
- RSRB_STUDY00005384
- Other IDs
- R01NS111057
- Acronym
- MRIA
- Status last verified
- Apr 2024
- First submitted
- 16 Feb 2023
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research data that documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers.
Publications
Rubin DB. Multiple Imputation for Nonresponse in Surveys. New York, NY: John Wiley and Sons, 1987.
Firth D. Bias reduction of maximum likelihood estimates. Biometrika 1993;80:27-38.
Plewes K, Turner GDH, Dondorp AM. Pathophysiology, clinical presentation, and treatment of coma and acute kidney injury complicating falciparum malaria. Curr Opin Infect Dis. 2018 Feb;31(1):69-77. doi: 10.1097/QCO.0000000000000419.
PubMed 29206655Potchen MJ, Birbeck GL, Demarco JK, Kampondeni SD, Beare N, Molyneux ME, Taylor TE. Neuroimaging findings in children with retinopathy-confirmed cerebral malaria. Eur J Radiol. 2010 Apr;74(1):262-8. doi: 10.1016/j.ejrad.2009.02.010. Epub 2009 Apr 3.
PubMed 19345538Potchen MJ, Kampondeni SD, Ibrahim K, Bonner J, Seydel KB, Taylor TE, Birbeck GL. NeuroInterp: a method for facilitating neuroimaging research on cerebral malaria. Neurology. 2013 Aug 6;81(6):585-8. doi: 10.1212/WNL.0b013e31829e6ed5.
PubMed 23918861Birbeck GL, Molyneux ME, Kaplan PW, Seydel KB, Chimalizeni YF, Kawaza K, Taylor TE. Blantyre Malaria Project Epilepsy Study (BMPES) of neurological outcomes in retinopathy-positive paediatric cerebral malaria survivors: a prospective cohort study. Lancet Neurol. 2010 Dec;9(12):1173-1181. doi: 10.1016/S1474-4422(10)70270-2. Epub 2010 Nov 4.
PubMed 21056005Carter JA, Lees JA, Gona JK, Murira G, Rimba K, Neville BG, Newton CR. Severe falciparum malaria and acquired childhood language disorder. Dev Med Child Neurol. 2006 Jan;48(1):51-7. doi: 10.1017/S0012162206000107.
PubMed 16359594Carter JA, Mung'ala-Odera V, Neville BG, Murira G, Mturi N, Musumba C, Newton CR. Persistent neurocognitive impairments associated with severe falciparum malaria in Kenyan children. J Neurol Neurosurg Psychiatry. 2005 Apr;76(4):476-81. doi: 10.1136/jnnp.2004.043893.
PubMed 15774431Carter JA, Neville BG, White S, Ross AJ, Otieno G, Mturi N, Musumba C, Newton CR. Increased prevalence of epilepsy associated with severe falciparum malaria in children. Epilepsia. 2004 Aug;45(8):978-81. doi: 10.1111/j.0013-9580.2004.65103.x.
PubMed 15270766Dondorp AM, Fanello CI, Hendriksen IC, Gomes E, Seni A, Chhaganlal KD, Bojang K, Olaosebikan R, Anunobi N, Maitland K, Kivaya E, Agbenyega T, Nguah SB, Evans J, Gesase S, Kahabuka C, Mtove G, Nadjm B, Deen J, Mwanga-Amumpaire J, Nansumba M, Karema C, Umulisa N, Uwimana A, Mokuolu OA, Adedoyin OT, Johnson WB, Tshefu AK, Onyamboko MA, Sakulthaew T, Ngum WP, Silamut K, Stepniewska K, Woodrow CJ, Bethell D, Wills B, Oneko M, Peto TE, von Seidlein L, Day NP, White NJ; AQUAMAT group. Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUAMAT): an open-label, randomised trial. Lancet. 2010 Nov 13;376(9753):1647-57. doi: 10.1016/S0140-6736(10)61924-1. Epub 2010 Nov 7.
PubMed 21062666Carter JA, Ross AJ, Neville BG, Obiero E, Katana K, Mung'ala-Odera V, Lees JA, Newton CR. Developmental impairments following severe falciparum malaria in children. Trop Med Int Health. 2005 Jan;10(1):3-10. doi: 10.1111/j.1365-3156.2004.01345.x.
PubMed 15655008Idro R, Jenkins NE, Newton CR. Pathogenesis, clinical features, and neurological outcome of cerebral malaria. Lancet Neurol. 2005 Dec;4(12):827-40. doi: 10.1016/S1474-4422(05)70247-7.
PubMed 16297841John CC, Bangirana P, Byarugaba J, Opoka RO, Idro R, Jurek AM, Wu B, Boivin MJ. Cerebral malaria in children is associated with long-term cognitive impairment. Pediatrics. 2008 Jul;122(1):e92-9. doi: 10.1542/peds.2007-3709. Epub 2008 Jun 9.
PubMed 18541616Severe and complicated malaria. World Health Organization, Division of Control of Tropical Diseases. Trans R Soc Trop Med Hyg. 1990;84 Suppl 2:1-65. No abstract available.
PubMed 2219249Corbett D, Thornhill J. Temperature modulation (hypothermic and hyperthermic conditions) and its influence on histological and behavioral outcomes following cerebral ischemia. Brain Pathol. 2000 Jan;10(1):145-52. doi: 10.1111/j.1750-3639.2000.tb00251.x.
PubMed 10668904
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An MRI Ancillary Study of a Malaria Fever Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT05746819
- Acronym / sponsor ID
- MRIA / RSRB_STUDY00005384
- Conditions
- Brain Injuries, Malaria, MRI Imaging, Neurocognitive Deficits, Chronic Kidney Diseases, Behavior Problem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will seek consent from parents of children enrolled in the Malaria FEVER study to obtain neuroimaging and 12-month neuropsychiatric outcomes data and kidney function on their child. The imaging and evaluations for this observational study will occur after the child has recovered from the acute malaria infection and has otherwise completed the RCT intervention and safety evaluations.
Detailed description
Despite eradication efforts, ~400,000 African children sustained brain injuries as a result of CNS malaria in 2016. A higher maximum temperature (Tmax) during the acute malaria infection is an established risk factor for neurologic sequelae and a randomized controlled trial (RCT) of aggressive antipyretic therapy with acetaminophen and ibuprofen conducted in Malawi and Zambia began enrollment in 2019 (R01NS102176). In that clinical trial, the primary outcome was Tmax during the acute infection. However, the antipyretic therapies used in this RCT may offer neuroprotective effects without affecting Tmax--for example, neuroprotection through anti-inflammatory mechanisms. In An MRI Ancillary Study of Malaria FEVER RCT, we propose to use neuroimaging in the context of the RCT to further evaluate the potential neuroprotective effects of aggressive antipyretic therapy for CNS malaria and explore possible mechanisms for these effects. Comparing children allocated to aggressive antipyretic therapy vs. usual care on the prevalence of structural brain abnormalities after recovery from CNS malaria will facilitate the evaluation of non-fever pathways for neuroprotection. Brain MRIs will be obtained in children enrolled in the RCT at 1- and 12-months post recovery. Analyses will be completed comparing the odds of having any structural injury based upon RCT treatment allocation and based upon (Tmax) stratified by treatment allocation to assess changes specifically related to response to therapy in terms of fever reduction. Potential mechanisms of aggressive antipyretic-related injury will be evaluated including assessments for treatment-related CNS bleeds. Neuroimaging is a well-established, valid proxy for neurological outcomes after brain injury including in pediatric CNS malaria. Adding this MRI ancillary study to our fever RCT may elucidate mechanisms of treatment-associated injury and allow for early identification of neuroprotection from aggressive antipyretic use that would otherwise require long-term follow-up for cognitive and behavioral assessments. This study will provide critical insights that could inform future neuroprotective studies of malaria that might incorporate imaging to optimize study design. It will also add to our understanding of the long term impact of severe malaria on chronic kidney disease risk in children.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children enrolled in the Malaria RCT who survive to discharge are eligible for enrollment.
Key inclusion criteria (3 listed)
- All children enrolled in the parent Malaria RCT study are eligible
- Signed parental consent is required
- CNS symptoms associated with malaria.
Key exclusion criteria (10 listed)
- Circulatory failure (cold extremities, capillary refill > 3 seconds, sunken eyes, ↓ skin turgor)
- Vomiting in the past 2 hours
- Serum Cr > 1.2 mg/dL
- A history of liver disease
- Jaundice or a total bilirubin of >3.0mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aggressive antipyretics therapy of fever vs usual care in the Malaria RCT studyAlso: NCT03399318After clinical trial of the Malaria RCT study, this study will compare children allocated to aggressive antipyretic therapy vs. usual care on the prevalence of structural brain abnormalities after recovery from CNS malaria. | Other | – |
Primary outcome
MRI neuroimaging 1a
Time frame: at 1 month
Children in the RCT will undergo brain MRIs at 1 month after their acute malaria illness to check for any structural injury following CNS malaria. Two radiologists, blinded to treatment allocation, will independently review images and identify the presence or absence of any injury (present vs absent) For children who are unable to tolerate imaging, brain injury status will be determined by outcomes from age-specific neurocognitive and behavioral assessments.
MRI neuroimaging 1a
Time frame: at 12 months
Children in the RCT will undergo brain MRIs at 12 months after their acute malaria illness to check for any structural injury following CNS malaria. Two radiologists, blinded to treatment allocation, will independently review images and identify the presence or absence of any injury (present vs absent) For children who are unable to tolerate imaging, brain injury status will be determined by outcomes from age-specific neurocognitive and behavioral assessments.
14 secondary outcomes
Comparing specific abnormalities in the two groups by allocation: Brain atrophy
Time frame: at 1 month post recovery
Comparing specific abnormalities in the two groups by allocation: Brain atrophy
Time frame: at 12 months post recovery
Comparing specific abnormalities in the two groups by allocation: Gliosis by Fazekas score
Time frame: 1 month post recovery
Comparing specific abnormalities in the two groups by allocation: Gliosis by Fazekas score
Time frame: 12 month post recovery
Comparing specific abnormalities in the two groups by allocation:The presence or absence of regional gliosis or atrophy in cortical region
Time frame: at 1 month post recovery
Comparing specific abnormalities in the two groups by allocation:The presence or absence of regional gliosis or atrophy in cortical region
Time frame: at 12 month post recovery
Comparing specific abnormalities in the two groups by allocation:The presence or absence of regional gliosis or atrophy in deep gray
Time frame: 1 month post recovery
Comparing specific abnormalities in the two groups by allocation:The presence or absence of regional gliosis or atrophy in deep gray
Time frame: 12 months post recovery
Comparing specific abnormalities in the two groups by allocation:The presence or absence of regional gliosis or atrophy in corpus callosum
Time frame: 1 month post recovery
Comparing specific abnormalities in the two groups by allocation:The presence of or absence regional gliosis or atrophy in corpus callosum
Time frame: 12 months post recovery
Comparing specific abnormalities in the two groups by allocation:The presence or absence of regional gliosis or atrophy in posterior fossa
Time frame: 1 month post recovery
Comparing specific abnormalities in the two groups by allocation:The presence or absence of regional gliosis or atrophy in posterior fossa
Time frame: at 12 months post recovery
Safety assessment: bleeding
Time frame: at 1-month
Safety assessment: kidney
Time frame: At least 6 months post malaria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- BackgroundRubin DB. Multiple Imputation for Nonresponse in Surveys. New York, NY: John Wiley and Sons, 1987.
- BackgroundFirth D. Bias reduction of maximum likelihood estimates. Biometrika 1993;80:27-38.
- Background: PubMed 29206655Plewes K, Turner GDH, Dondorp AM. Pathophysiology, clinical presentation, and treatment of coma and acute kidney injury complicating falciparum malaria. Curr Opin Infect Dis. 2018 Feb;31(1):69-77. doi: 10.1097/QCO.0000000000000419.
- Results publication: PubMed 19345538Potchen MJ, Birbeck GL, Demarco JK, Kampondeni SD, Beare N, Molyneux ME, Taylor TE. Neuroimaging findings in children with retinopathy-confirmed cerebral malaria. Eur J Radiol. 2010 Apr;74(1):262-8. doi: 10.1016/j.ejrad.2009.02.010. Epub 2009 Apr 3.
- Results publication: PubMed 23918861Potchen MJ, Kampondeni SD, Ibrahim K, Bonner J, Seydel KB, Taylor TE, Birbeck GL. NeuroInterp: a method for facilitating neuroimaging research on cerebral malaria. Neurology. 2013 Aug 6;81(6):585-8. doi: 10.1212/WNL.0b013e31829e6ed5.
- Results publication: PubMed 21056005Birbeck GL, Molyneux ME, Kaplan PW, Seydel KB, Chimalizeni YF, Kawaza K, Taylor TE. Blantyre Malaria Project Epilepsy Study (BMPES) of neurological outcomes in retinopathy-positive paediatric cerebral malaria survivors: a prospective cohort study. Lancet Neurol. 2010 Dec;9(12):1173-1181. doi: 10.1016/S1474-4422(10)70270-2. Epub 2010 Nov 4.
- Results publication: PubMed 16359594Carter JA, Lees JA, Gona JK, Murira G, Rimba K, Neville BG, Newton CR. Severe falciparum malaria and acquired childhood language disorder. Dev Med Child Neurol. 2006 Jan;48(1):51-7. doi: 10.1017/S0012162206000107.
- Results publication: PubMed 15774431Carter JA, Mung'ala-Odera V, Neville BG, Murira G, Mturi N, Musumba C, Newton CR. Persistent neurocognitive impairments associated with severe falciparum malaria in Kenyan children. J Neurol Neurosurg Psychiatry. 2005 Apr;76(4):476-81. doi: 10.1136/jnnp.2004.043893.
- Results publication: PubMed 15270766Carter JA, Neville BG, White S, Ross AJ, Otieno G, Mturi N, Musumba C, Newton CR. Increased prevalence of epilepsy associated with severe falciparum malaria in children. Epilepsia. 2004 Aug;45(8):978-81. doi: 10.1111/j.0013-9580.2004.65103.x.
- Results publication: PubMed 21062666Dondorp AM, Fanello CI, Hendriksen IC, Gomes E, Seni A, Chhaganlal KD, Bojang K, Olaosebikan R, Anunobi N, Maitland K, Kivaya E, Agbenyega T, Nguah SB, Evans J, Gesase S, Kahabuka C, Mtove G, Nadjm B, Deen J, Mwanga-Amumpaire J, Nansumba M, Karema C, Umulisa N, Uwimana A, Mokuolu OA, Adedoyin OT, Johnson WB, Tshefu AK, Onyamboko MA, Sakulthaew T, Ngum WP, Silamut K, Stepniewska K, Woodrow CJ, Bethell D, Wills B, Oneko M, Peto TE, von Seidlein L, Day NP, White NJ; AQUAMAT group. Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUAMAT): an open-label, randomised trial. Lancet. 2010 Nov 13;376(9753):1647-57. doi: 10.1016/S0140-6736(10)61924-1. Epub 2010 Nov 7.
- Results publication: PubMed 15655008Carter JA, Ross AJ, Neville BG, Obiero E, Katana K, Mung'ala-Odera V, Lees JA, Newton CR. Developmental impairments following severe falciparum malaria in children. Trop Med Int Health. 2005 Jan;10(1):3-10. doi: 10.1111/j.1365-3156.2004.01345.x.
- Results publication: PubMed 16297841Idro R, Jenkins NE, Newton CR. Pathogenesis, clinical features, and neurological outcome of cerebral malaria. Lancet Neurol. 2005 Dec;4(12):827-40. doi: 10.1016/S1474-4422(05)70247-7.
- Individual participant dataSharing planned: Yes. Research data that documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl B Seydel, PhD principal investigator
Michigan State University, USA
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries and Malaria, run by University of Rochester at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malawi, Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI neuroimaging 1a (time frame: at 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05746819, which also lists 68 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.