Treating Brain Swelling in Pediatric Cerebral Malaria

Michigan State University57 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Malaria, Cerebral

Interventions

Mechanical ventilationOTHER

Intubation and mechanical ventilation for a maximum of 7 days

Hypertonic salineDRUG

Intravenous 3 percent hypertonic saline for a maximum of 7 days

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

Queen Elizabeth Central Hospital

Blantyre, Malawi

Outcomes

Primary Outcomes

Number of Participants Who Died

Alive or dead

Time frame: Within 7 days of randomization

Secondary Outcomes

Neurodevelopmental Disability

Presence and severity of neurodevelopmental disability in survivors

Time frame: 1 year

Data from ClinicalTrials.gov

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