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| ID | Type | Description | Link |
|---|---|---|---|
| U01AI126610 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Children's National Research Institute | OTHER |
| Nationwide Children's Hospital | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | 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 | |
| Mechanical ventilation | Experimental | 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 |
|
| Hypertonic saline | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical ventilation | Other | Intubation and mechanical ventilation for a maximum of 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Died | Alive or dead | Within 7 days of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Neurodevelopmental Disability | Presence and severity of neurodevelopmental disability in survivors | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terrie E Taylor, DO | Michigan State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Central Hospital | Blantyre | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34020114 | Derived | Postels DG. Leveling the Playing Field: Combining Pediatric Neurology and Global Health. Pediatr Neurol. 2021 Jul;120:61-62. doi: 10.1016/j.pediatrneurol.2021.04.012. Epub 2021 Apr 25. No abstract available. |
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Deidentified individual participant data may be made available to other researchers
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Starting 6 months after publication
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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)
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Mechanical Ventilation | Intubation and mechanical ventilation at the time of randomization |
| FG001 | Hypertonic Saline | Treatment as usual plus continuous infusion of intravenous 3 percent hypertonic saline |
| FG002 | Controls (Treatment as Usual) | Treatment as usual |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mechanical Ventilation | Intubation and mechanical ventilation at the time of randomization |
| BG001 | Hypertonic Saline | Treatment as usual plus continuous infusion of intravenous 3 percent hypertonic saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Died | Alive or dead | Posted | Count of Participants | Participants | Within 7 days of randomization |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mechanical Ventilation | Intubation and mechanical ventilation at the time of randomization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | Systematic Assessment |
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Low enrollment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terrie E. Taylor | Michigan State University | 5178988467 | ttmalawi@msu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2023 | Jan 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016779 | Malaria, Cerebral |
| D003128 | Coma |
| ID | Term |
|---|---|
| D020808 | Central Nervous System Protozoal Infections |
| D020807 | Central Nervous System Parasitic Infections |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D012462 | Saline Solution, Hypertonic |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012151 | Resuscitation |
| D004638 | Emergency Treatment |
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| University of Maryland, Baltimore |
| OTHER |
| Kamuzu University of Health Sciences | OTHER |
Participants will be randomly assigned to one of three study arms.
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Investigators assessing outcome will be blinded to the arm to which the participant was randomly assigned
| Hypertonic saline | Drug | Intravenous 3 percent hypertonic saline for a maximum of 7 days |
|
| BG002 | Controls (Treatment as Usual) | Treatment as usual |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participant |
|
|
|
| Secondary | Neurodevelopmental Disability | Presence and severity of neurodevelopmental disability in survivors | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 5 |
| 23 |
| 4 |
| 23 |
| 0 |
| 23 |
| EG001 | Hypertonic Saline | Treatment as usual plus continuous infusion of intravenous 3 percent hypertonic saline | 5 | 17 | 1 | 17 | 0 | 17 |
| EG002 | Controls (Treatment as Usual) | Treatment as usual | 5 | 17 | 2 | 17 | 0 | 17 |
| Respiratory problems from ventilator | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D010272 | Parasitic Diseases |
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012138 |
| Respiratory Therapy |
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |