Treating Brain Swelling in Pediatric Cerebral Malaria

• Status: Recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michigan State University
• Collaborators: Children's National Research Institute; National Institute of Allergy and Infectious Diseases (NIAID); Nationwide Children's Hospital; University of Malawi College of Medicine; University of Maryland, Baltimore

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