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OpenTrials
Completed

NCT Number: NCT03300648

Treating Brain Swelling in Pediatric Cerebral Malaria

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical ventilation

Other

Intubation and mechanical ventilation for a maximum of 7 days

Hypertonic saline

Drug

Intravenous 3 percent hypertonic saline for a maximum of 7 days

Primary outcomes

  1. Number of Participants Who Died

    Time frame: Within 7 days of randomization

    Alive or dead

Secondary outcomes

  1. Neurodevelopmental Disability

    Time frame: 1 year

    Presence and severity of neurodevelopmental disability in survivors

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • 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

Registry information

Acronym: TBS

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 3, 2017
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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