Treating Brain Swelling in Pediatric Cerebral Malaria

• Register: ClinicalTrials.gov
• Last refreshed on: 12 February 2024
• Main ID: NCT03300648
• Date of registration: 28/09/2017
• Prospective Registration: Yes
• Primary sponsor: Michigan State University
• Public title: Treating Brain Swelling in Pediatric Cerebral Malaria TBS
• Scientific title: Treating Brain Swelling in Pediatric Cerebral Malaria
• Date of first enrolment: January 8, 2018
• Target sample size: 206
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03300648
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Malawi

Contacts

• Name: Terrie E Taylor, DO
• Affiliation: Michigan State University

Key inclusion & exclusion 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



Age minimum: 6 Months
Age maximum: 12 Years
Gender: All

Health Condition(s) or Problem(s) studied

Malaria, Cerebral

Intervention(s)

Other: Mechanical ventilation

Drug: Hypertonic saline

Primary Outcome(s)

Mortality [Time Frame: Within 7 days of randomization]

Secondary Outcome(s)

Neurodevelopmental disability [Time Frame: 1 year]

Secondary ID(s)

TBS

U01AI126610

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Children's National Research Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Kamuzu University of Health Sciences

Nationwide Children's Hospital

University of Maryland, Baltimore