Treating Brain Swelling in Pediatric Cerebral Malaria

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2023-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Malaria, Cerebral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to one of three study arms.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Investigators assessing outcome will be blinded to the arm to which the participant was randomly assigned

Study Groups

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Usual care

Hospitalization in a high dependency pediatric unit with skilled nursing, intravenous artesunate followed by oral artemisinin combination therapy, intravenous fluids, nasogastric feeding, elevation of the head of the bed by 30 degrees

Group Type NO_INTERVENTION

No interventions assigned to this group

Mechanical ventilation

Hospitalization in a high dependency pediatric unit with skilled nursing, intravenous artesunate followed by oral artemisinin combination therapy, intravenous fluids, nasogastric feeding, elevation of the head of the bed by 30 degrees, along with intubation and mechanical ventilation for a maximum of 7 days

Group Type EXPERIMENTAL

Mechanical ventilation

Intervention Type OTHER

Intubation and mechanical ventilation for a maximum of 7 days

Hypertonic saline

Hospitalization in a high dependency pediatric unit with skilled nursing, intravenous artesunate followed by oral artemisinin combination therapy, intravenous fluids, nasogastric feeding, elevation of the head of the bed by 30 degrees, along with intravenous 3% hypertonic saline for a maximum of 7 days

Group Type EXPERIMENTAL

Hypertonic saline

Intervention Type DRUG

Intravenous 3 percent hypertonic saline for a maximum of 7 days

Interventions

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Mechanical ventilation

Intubation and mechanical ventilation for a maximum of 7 days

Intervention Type OTHER

Hypertonic saline

Intravenous 3 percent hypertonic saline for a maximum of 7 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No