NCT05746819Completed
An MRI Ancillary Study of a Malaria Fever Investigation
An MRI Ancillary Study of a Malaria Fever Randomized Controlled Trial (RCT)
Source: ClinicalTrials.gov · Last updated 15 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 181 (actual)
- First submitted
- 16 Feb 2023
- Start date
- 2 Jan 2021
- Primary completion date
- 31 Aug 2023
- Lead sponsor
- University of Rochester
- Diseases
- Chronic kidney disease
- NCT number
- NCT05746819
What you commit to
- Study type: Observational
- Participants enrolled: 181
- From 2 Jan 2021 to the primary completion date, 31 Aug 2023
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any contraindication for nasogastric tube (NGT) placement and/or delivery of enteral medications
Other illness
- Circulatory failure (cold extremities, capillary refill \> 3 seconds, sunken eyes, ↓ skin turgor)
- A history of liver disease
- 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
- A known allergy to ibuprofen, acetaminophen, aspirin or any non-steroidal medication
Lab values
- Serum Cr \> 1.2 mg/dL
- Jaundice or a total bilirubin of \>3.0mg/dL
Other
- Vomiting in the past 2 hours
Who the study is looking for
- All children enrolled in the parent Malaria RCT study are eligible
- Signed parental consent is required
- CNS symptoms associated with malaria.
Age in the registry: 2 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queen Elizabeth Central Hospital Coordinator of this site? Confirm its status | Blantyre | Malawi | Unknown status |
| Chipata Central Hospital Coordinator of this site? Confirm its status | Chipata | Zambia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.