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Treating Brain Swelling in Pediatric Cerebral Malaria

NCT03300648 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-03-17

Study results available
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Summary

This study evaluates the effectiveness of two interventions in Malawian children with cerebral malaria at high risk of death. One-third of the participants will receive treatment as usual, one-third will receive treatment as usual and be placed on a mechanical ventilator, and one-third will receive treatment as usual plus intravenous hypertonic saline.

Conditions

  • Malaria, Cerebral

Interventions

OTHER

Mechanical ventilation

Intubation and mechanical ventilation for a maximum of 7 days

DRUG

Hypertonic saline

Intravenous 3 percent hypertonic saline for a maximum of 7 days

Sponsors & Collaborators

  • Children's National Research Institute

    collaborator OTHER

  • Nationwide Children's Hospital

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Maryland, Baltimore

    collaborator OTHER

  • Kamuzu University of Health Sciences

    collaborator OTHER

  • Michigan State University

    lead OTHER

Principal Investigators

  • Terrie E Taylor, DO · Michigan State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • Malawi

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03300648 on ClinicalTrials.gov