Trial · NCT03300648
Treating Brain Swelling in Pediatric Cerebral Malaria
NCT03300648, Phase 3, Completed, Michigan State University; results first posted 2025-03-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treating Brain Swelling in Pediatric Cerebral Malaria. Trials, record NCT03300648. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03300648
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treating Brain Swelling in Pediatric Cerebral Malaria
- NCT number
- NCT03300648
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 57 participants, actual
- Lead sponsor
- Michigan State University
- Conditions
- Malaria, Cerebral
- Interventions
- Mechanical ventilation, Hypertonic saline
- First posted
- 2017-10-03
- Last updated
- 2025-03-17
- Results first posted
- 2025-03-17
- Limitations and caveats
- Low enrollment
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Died | Within 7 days of randomization | Alive or dead |
| Secondary | Neurodevelopmental Disability | 1 year | Presence and severity of neurodevelopmental disability in survivors |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Died | Within 7 days of randomization | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Neurodevelopmental Disability | 1 year | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Died | Mechanical Ventilation | 5 | Participants | ||
| Number of Participants Who Died | Hypertonic Saline | 5 | Participants | ||
| Number of Participants Who Died | Treatment as Usual | 5 | Participants | ||
| Neurodevelopmental Disability | Mechanical Ventilation | 5 | Participants | ||
| Neurodevelopmental Disability | Hypertonic Saline | 4 | Participants | ||
| Neurodevelopmental Disability | Controls (Treatment as Usual) | 1 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mechanical Ventilation | 23 | |
| Overall Study | STARTED | Hypertonic Saline | 17 | |
| Overall Study | STARTED | Controls (Treatment as Usual) | 17 | |
| Overall Study | COMPLETED | Mechanical Ventilation | 23 | |
| Overall Study | COMPLETED | Hypertonic Saline | 17 | |
| Overall Study | COMPLETED | Controls (Treatment as Usual) | 17 | |
| Overall Study | NOT COMPLETED | Mechanical Ventilation | 0 | |
| Overall Study | NOT COMPLETED | Hypertonic Saline | 0 | |
| Overall Study | NOT COMPLETED | Controls (Treatment as Usual) | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Sepsis | Infections and infestations | Mechanical Ventilation | 1 | 23 | 1 |
| serious | Sepsis | Infections and infestations | Hypertonic Saline | 1 | 17 | 1 |
| serious | Sepsis | Infections and infestations | Controls (Treatment as Usual) | 2 | 17 | 2 |
| serious | Respiratory problems from ventilator | Respiratory, thoracic and mediastinal disorders | Mechanical Ventilation | 3 | 23 | 3 |
| serious | Respiratory problems from ventilator | Respiratory, thoracic and mediastinal disorders | Hypertonic Saline | 0 | 17 | 0 |
| serious | Respiratory problems from ventilator | Respiratory, thoracic and mediastinal disorders | Controls (Treatment as Usual) | 0 | 17 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mechanical Ventilation | 5 | 23 |
| Total, all-cause mortality | Hypertonic Saline | 5 | 17 |
| Total, all-cause mortality | Controls (Treatment as Usual) | 5 | 17 |
| Total, other adverse events | Mechanical Ventilation | 0 | 23 |
| Total, other adverse events | Hypertonic Saline | 0 | 17 |
| Total, other adverse events | Controls (Treatment as Usual) | 0 | 17 |
| Total, serious adverse events | Mechanical Ventilation | 4 | 23 |
| Total, serious adverse events | Hypertonic Saline | 1 | 17 |
| Total, serious adverse events | Controls (Treatment as Usual) | 2 | 17 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34020114 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01AI126610 | Treating Brain Swelling in Pediatric Cerebral Malaria | TAYLOR, TERRIE ELLEN | MICHIGAN STATE UNIVERSITY | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2017 to 2023 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03300648
GET https://conductscience.org/api/trials/v1/NCT03300648/registered