An MRI Ancillary Study of a Malaria Fever Investigation

NCT05746819 | Completed

• 2 other identifiers: RSRB_STUDY00005384R01NS111057
• Study Type: observational
• Target: 181
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Brain Injuries; Malaria; MRI Imaging; Neurocognitive Deficits; Chronic Kidney Diseases; Behavior Problem

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  at 12 months

Secondary Outcomes (14)

• Comparing specific abnormalities in the two groups by allocation: Brain atrophy

  at 1 month post recovery

• Comparing specific abnormalities in the two groups by allocation: Brain atrophy

  at 12 months post recovery

• Comparing specific abnormalities in the two groups by allocation: Gliosis by Fazekas score

  1 month post recovery

• Comparing specific abnormalities in the two groups by allocation: Gliosis by Fazekas score

  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

  at 1 month post recovery

Interventions

Aggressive antipyretics therapy of fever vs usual care in the Malaria RCT study OTHER

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.

Also known as: NCT03399318

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All children enrolled in the Malaria RCT who survive to discharge are eligible for enrollment.

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

Queen Elizabeth Central Hospital

Blantyre, Southern Region, Malawi

Location

Chipata Central Hospital

Chipata, Eastern Province, Zambia

Location

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MeSH Terms

Conditions

Brain Injuries; Malaria; Renal Insufficiency, Chronic; Mental Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karl B Seydel, PhD

  Michigan State University, USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 28, 2023
• Study Start: January 2, 2021
• Primary Completion: August 31, 2023
• Study Completion: March 31, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1-year after study completion
• Access Criteria: reasonable written request

Locations

MA (1); ZA (1)