Status:
COMPLETED
Treating Brain Swelling in Pediatric Cerebral Malaria
Lead Sponsor:
Michigan State University
Collaborating Sponsors:
Children's National Research Institute
Nationwide Children's Hospital
Conditions:
Malaria, Cerebral
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief 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 w...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03300648
Start Date
January 8 2018
End Date
December 31 2023
Last Update
March 17 2025
Active Locations (1)
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1
Queen Elizabeth Central Hospital
Blantyre, Malawi