Treating Brain Swelling in Pediatric Cerebral Malaria (TBS)
Malaria, Cerebral
About this trial
This is an interventional treatment trial for Malaria, Cerebral focused on measuring coma, pediatrics
Eligibility Criteria
Inclusion Criteria:
- Peripheral P. falciparum parasitemia of any density
- Blantyre Coma Score ≤2
- No evidence of meningitis on lumbar puncture
- Consciousness not regained after correction of hypoglycemia (if hypoglycemia is present)
- Male or female whose age on the day of screening is between 6 months and 12 years old
- Severely increased brain volume on magnetic resonance imaging
- Provision of consent by guardian
- Willingness to return for 1, 6, and 12 month post-randomization follow-up visits
Exclusion Criteria:
- Gross malnutrition as evidenced by peripheral edema, hair color changes, or severe wasting
- Advanced Human Immunodeficiency Virus (HIV) disease - defined as known HIV positive status and evidence of severe wasting
- Evidence of recent head trauma by history or physical examination
- Pneumonia as evidenced by oxygen saturation on room air of <85%
- Gastroenteritis and shock as evidenced by capillary refill >3 seconds or skin tenting
Sites / Locations
- Queen Elizabeth Central HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Experimental
Experimental
Unual care
Mechanical ventilation
Hypertonic saline
Hospitalization in a high dependency pediatric unit with skilled nursing, intravenous artesunate followed by oral artemisinin combination therapy, intravenous fluids, nasogastric feeding, elevation of the head of the bed by 30 degrees
Hospitalization in a high dependency pediatric unit with skilled nursing, intravenous artesunate followed by oral artemisinin combination therapy, intravenous fluids, nasogastric feeding, elevation of the head of the bed by 30 degrees, along with intubation and mechanical ventilation for a maximum of 7 days
Hospitalization in a high dependency pediatric unit with skilled nursing, intravenous artesunate followed by oral artemisinin combination therapy, intravenous fluids, nasogastric feeding, elevation of the head of the bed by 30 degrees, along with intravenous 3% hypertonic saline for a maximum of 7 days