Phase 3
Completed N=57
Treating Brain Swelling in Pediatric Cerebral Malaria
Malaria, Cerebral
Source: ClinicalTrials.gov NCT03300648 ↗
Enrolled (actual)
57
Serious AEs
12.3%
Results posted
Mar 2025
Primary outcomePrimary: Number of Participants Who Died — 5; 5; 5 Participants
◆ Published Evidence
Not yet cited
0citations
Leveling the Playing Field: Combining Pediatric Neurology and Global Health.
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.
Linked Publications
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Leveling the Playing Field: Combining Pediatric Neurology and Global Health.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Died |
5; 5; 5 | — |
| SECONDARY Neurodevelopmental Disability |
5; 4; 1 | — |
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 3 seconds or skin tenting
Data sourced from ClinicalTrials.gov (NCT03300648) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.