Queen Elizabeth Central Hospital
Blantyre, Malawi
NCT Number: NCT03300648
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.
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Notify Me6 month–12 year
All sexes
Interventional
Phase 3
Blantyre, Malawi
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intubation and mechanical ventilation for a maximum of 7 days
Intravenous 3 percent hypertonic saline for a maximum of 7 days
Time frame: Within 7 days of randomization
Alive or dead
Time frame: 1 year
Presence and severity of neurodevelopmental disability in survivors
Michigan State University
Other
Acronym: TBS
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