Clinical trial NCT03300648: Treating Brain Swelling in Pediatric Cerebral Malaria
Official title: Treating Brain Swelling in Pediatric Cerebral Malaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria, Cerebral
Keywords: coma
pediatrics
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Children's National Research Institute
name: Nationwide Children's Hospital
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: University of Maryland, Baltimore
name: Kamuzu University of Health Sciences
First posted: 2017-10-03
Enrollment: 57
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of three study arms.
Primary purpose: TREATMENT

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 will receive treatment as usual and be placed on a mechanical ventilator, and one-third will receive treatment as usual plus intravenous hypertonic saline.

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 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.

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

Primary outcomes:
measure: Number of Participants Who Died
timeFrame: Within 7 days of randomization
Secondary outcomes:
measure: Neurodevelopmental Disability
timeFrame: 1 year
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Queen Elizabeth Central Hospital
Study officials:
affiliation: Michigan State University
name: Terrie E Taylor, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Postels DG. Leveling the Playing Field: Combining Pediatric Neurology and Global Health. Pediatr Neurol. 2021 Jul;120:61-62. doi: 10.1016/j.pediatrneurol.2021.04.012. Epub 2021 Apr 25. No abstract available.