Trial Outcomes & Findings for Treating Brain Swelling in Pediatric Cerebral Malaria (NCT NCT03300648)

NCT ID: NCT03300648

Last Updated: 2025-03-17

Results Overview

Alive or dead

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 57 participants
• Primary outcome timeframe: Within 7 days of randomization
• Results posted on: 2025-03-17

Participant Flow

Participants recruited from 8 January 2018 through 24 May 2023. Children were recruited from Queen Elizabeth Central Hospital and were referred in from 6 surrounding District Hospitals, all in southern Malawi

Enrolled participants underwent screening brain magnetic resonance imaging. If the images showed highly increased brain volume (brain volume scores of 6-8) they were randomized to immediate ventilation, intravenous hypertonic saline, or treatment as usual (controls)

Participant milestones

Measure	Mechanical Ventilation Intubation and mechanical ventilation at the time of randomization	Hypertonic Saline Treatment as usual plus continuous infusion of intravenous 3 percent hypertonic saline	Controls (Treatment as Usual) Treatment as usual
Overall Study STARTED	23	17	17
Overall Study COMPLETED	23	17	17
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treating Brain Swelling in Pediatric Cerebral Malaria

Baseline characteristics by cohort

Measure	Mechanical Ventilation n=23 Participants Intubation and mechanical ventilation at the time of randomization	Hypertonic Saline n=17 Participants Treatment as usual plus continuous infusion of intravenous 3 percent hypertonic saline	Controls (Treatment as Usual) n=17 Participants Treatment as usual	Total n=57 Participants Total of all reporting groups
Age, Continuous	5.1 Years STANDARD_DEVIATION 3.1 • n=5 Participants	5.8 Years STANDARD_DEVIATION 4.1 • n=7 Participants	6.5 Years STANDARD_DEVIATION 3.5 • n=5 Participants	5.9 Years STANDARD_DEVIATION 3.3 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	22 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	35 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	23 Participants n=5 Participants	17 Participants n=7 Participants	17 Participants n=5 Participants	57 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Malawi	23 participant n=5 Participants	17 participant n=7 Participants	17 participant n=5 Participants	57 participant n=4 Participants

PRIMARY outcome

Timeframe: Within 7 days of randomization

Alive or dead

Outcome measures

Measure	Mechanical Ventilation n=23 Participants Intubation and mechanical ventilation at the time of randomization	Hypertonic Saline n=17 Participants Treatment as usual plus continuous infusion of intravenous 3 percent hypertonic saline	Treatment as Usual n=17 Participants Treatment as usual
Number of Participants Who Died	5 Participants	5 Participants	5 Participants

SECONDARY outcome

Timeframe: 1 year

Presence and severity of neurodevelopmental disability in survivors

Outcome measures

Measure	Mechanical Ventilation n=18 Participants Intubation and mechanical ventilation at the time of randomization	Hypertonic Saline n=12 Participants Treatment as usual plus continuous infusion of intravenous 3 percent hypertonic saline	Treatment as Usual n=12 Participants Treatment as usual
Neurodevelopmental Disability	5 Participants	4 Participants	1 Participants

Adverse Events

Mechanical Ventilation

Serious events: 4 serious events

Other events: 0 other events

Deaths: 5 deaths

Hypertonic Saline

Serious events: 1 serious events

Other events: 0 other events

Deaths: 5 deaths

Controls (Treatment as Usual)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Measure	Mechanical Ventilation n=23 participants at risk Intubation and mechanical ventilation at the time of randomization	Hypertonic Saline n=17 participants at risk Treatment as usual plus continuous infusion of intravenous 3 percent hypertonic saline	Controls (Treatment as Usual) n=17 participants at risk Treatment as usual
Infections and infestations Sepsis	4.3% 1/23 • Number of events 1 • 1 year	5.9% 1/17 • Number of events 1 • 1 year	11.8% 2/17 • Number of events 2 • 1 year
Respiratory, thoracic and mediastinal disorders Respiratory problems from ventilator	13.0% 3/23 • Number of events 3 • 1 year	0.00% 0/17 • 1 year	0.00% 0/17 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Terrie E. Taylor

Michigan State University

Phone: 5178988467

Email: ttmalawi@msu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place