CompletedNot Applicable

An MRI Ancillary Study of a Malaria Fever Investigation

Malawi, Zambia181 participantsStarted 2021-01-02

Plain-language 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. 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.

Who can participate

Age range2 Years – 12 Years

SexALL

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Inclusion criteria

✓. All children enrolled in the parent Malaria RCT study are eligible
✓. Signed parental consent is required
✓. CNS symptoms associated with malaria.

Exclusion criteria

✕. 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
✕. A history of thrombocytopenia or other primary hematologic disorder
✕. Petechiae or other clinical indications of bleeding abnormalities

What they're measuring

MRI neuroimaging 1a

Timeframe: at 1 month

MRI neuroimaging 1a

Timeframe: at 12 months

Trial details

NCT IDNCT05746819

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-08-31

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