Treating Brain Swelling in Pediatric Cerebral Malaria

Malaria, Cerebral Clinical Trial

— TBS  

Official title:

Treating Brain Swelling in Pediatric Cerebral Malaria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03300648
• Other study ID #: TBS
• Secondary ID: U01AI126610
• Status: Completed
• Phase: Phase 3
• Start date: January 8, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Edema
• Malaria
• Malaria, Cerebral

Intervention

Other:
• Mechanical ventilation
Intubation and mechanical ventilation for a maximum of 7 days

Drug:
• Hypertonic saline
Intravenous 3 percent hypertonic saline for a maximum of 7 days

Locations

Country	Name	City	State
Malawi	Queen Elizabeth Central Hospital	Blantyre

Sponsors (6)

Lead Sponsor	Collaborator
Michigan State University	Children's National Research Institute, Kamuzu University of Health Sciences, National Institute of Allergy and Infectious Diseases (NIAID), Nationwide Children's Hospital, University of Maryland, Baltimore

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Alive or dead	Within 7 days of randomization
Secondary	Neurodevelopmental disability	Presence and severity of neurodevelopmental disability in survivors	1 year