NCT03300648

Treating Brain Swelling in Pediatric Cerebral Malaria

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Michigan State University · Academic / Other
• Sex: All
• Age: 6 Months – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

An important mechanism of death in children with cerebral malaria is diffuse cerebral swelling, cerebral herniation, compression of the brainstem respiratory center, and respiratory arrest. In those who survive their illness without specific interventions, reversal of diffuse cerebral swelling is rapid. Mechanical ventilation may help to preserve life while diffuse brain swelling diminishes. Intravenous hypertonic saline may work as an osmotic diuretic, directly decreasing brain swelling.

Conditions

• Malaria, Cerebral

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-01-08
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2017-10-03
• Last updated: 2025-03-17
• Results posted: 2025-03-17

Locations

1 site across 1 country: Malawi

Regulatory

• FDA-regulated drug study