A Phase 3 interventional study of Mechanical ventilation and Hypertonic saline in Malaria, Cerebral, sponsored by Michigan State University. Completed at 1 site in Malawi. Open to participants aged 6 Months to 12 Years. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by Michigan State University · Phase 3, Interventional, and Treatment
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.
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.
138 studies on the registry are indexed under Coma; 35 are open to participants now.
This study's enrollment of 57 is below the median of 85 across 77 interventional studies indexed under Coma.
Browse Coma studies →Michigan State University is the lead sponsor of 143 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Other: 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 intravenous 3% hypertonic saline for a maximum of 7 days
Drug: Hypertonic saline
Intubation and mechanical ventilation for a maximum of 7 days
Intravenous 3 percent hypertonic saline for a maximum of 7 days
Number of Participants Who Died
Alive or dead
Time frame: Within 7 days of randomization
Neurodevelopmental Disability
Presence and severity of neurodevelopmental disability in survivors
Time frame: 1 year
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
| Milestone | Mechanical Ventilation | Hypertonic Saline | Controls (Treatment as Usual) |
|---|---|---|---|
| Started | 23 | 17 | 17 |
| Completed | 23 | 17 | 17 |
| Not completed | 0 | 0 | 0 |
Alive or dead
| Participants | Mechanical Ventilation | Hypertonic Saline | Treatment as Usual |
|---|---|---|---|
| Number of Participants Who Died | 5 | 5 | 5 |
Presence and severity of neurodevelopmental disability in survivors
| Participants | Mechanical Ventilation | Hypertonic Saline | Controls (Treatment as Usual) |
|---|---|---|---|
| Neurodevelopmental Disability | 5 | 4 | 1 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mechanical Ventilation | 5/23 (21.7%) | 4/23 (17.4%) | 0/23 (0%) |
| Hypertonic Saline | 5/17 (29.4%) | 1/17 (5.9%) | 0/17 (0%) |
| Controls (Treatment as Usual) | 5/17 (29.4%) | 2/17 (11.8%) | 0/17 (0%) |
| Event | Mechanical Ventilation | Hypertonic Saline | Controls (Treatment as Usual) |
|---|---|---|---|
| Respiratory problems from ventilatorRespiratory, thoracic and mediastinal disorders | 3/23 | 0/17 | 0/17 |
| SepsisInfections and infestations | 1/23 | 1/17 | 2/17 |
| Age, Continuous(Years) | Mechanical Ventilation | Hypertonic Saline | Controls (Treatment as Usual) | Total |
|---|---|---|---|---|
| Mean | 5.1 ± 3.1 | 5.8 ± 4.1 | 6.5 ± 3.5 | 5.9 ± 3.3 |
| Sex: Female, Male(Participants) | Mechanical Ventilation | Hypertonic Saline | Controls (Treatment as Usual) | Total |
|---|---|---|---|---|
| Female | 8 | 6 | 8 | 22 |
| Male | 15 | 11 | 9 | 35 |
| Race (NIH/OMB)(Participants) | Mechanical Ventilation | Hypertonic Saline | Controls (Treatment as Usual) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 23 | 17 | 17 | 57 |
| White | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participant) | Mechanical Ventilation | Hypertonic Saline | Controls (Treatment as Usual) | Total |
|---|---|---|---|---|
| Malawi | 23 | 17 | 17 | 57 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Deidentified individual participant data may be made available to other researchers
Time frame: Starting 6 months after publication
Ran from Jan 2018 to primary completion in Dec 2023, 71 months.
Results were first posted in Mar 2025, 1 year 2 months after primary completion.
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