- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03260413
Pneumonia Chart Review Cambodia
March 23, 2018 updated by: University of Minnesota
Quantifying the Burden of Hospitalizations for Pneumonia Among Children in Rural
This study aims to answer the question of what is the burden of lower respiratory disease (pneumonia) among children ages 1 month to 5 years of age in rural Cambodia.
The primary objective will be to quantify the prevalence of severe pneumonia at Chenla Children's Healthcare, a hospital in the rural town of Kratie, Cambodia.
This will involve a chart review of the medical records available at Chenla Children's Healthcare.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study population will be children between the ages of 1 month and 5 years who were admitted to Chenla Children's Healthcare with at least one admitting diagnosis being "pneumonia" or "bronchiolitis".
These children will be residents of Kratie province, Cambodia.
They are admitted to Chenla Children's Healthcare by way of their emergency department.
Description
Inclusion Criteria:
- Children between the ages of 1 month and 5 years admitted to Chenla Children's Healthcare with at least one admitting diagnosis being pneumonia or bronchiolitis will be included.
Exclusion Criteria:
- Children who do not fall into the aforementioned age range and who do not have "pneumonia" or "bronchiolitis" as one of the admitted diagnoses.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Pneumonia cases
Children between the ages of 1 month through 5 years of age who are admitted to Chenla Children's Healthcare between opening of the hospital (mid-2017) and early February 2018 for pneumonia and respiratory distress.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pneumonia count
Time Frame: 5-6 months
|
Number of admissions for pneumonia to Chenla Children's healthcare
|
5-6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 12, 2018
Primary Completion (Anticipated)
March 9, 2018
Study Completion (Anticipated)
March 9, 2018
Study Registration Dates
First Submitted
August 21, 2017
First Submitted That Met QC Criteria
August 21, 2017
First Posted (Actual)
August 24, 2017
Study Record Updates
Last Update Posted (Actual)
March 27, 2018
Last Update Submitted That Met QC Criteria
March 23, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000091
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data from this chart review will be used to inform baseline information of a larger study that is currently in the planning stages.
All investigators participating in this chart review are also investigators in this larger study.
Information from this chart review will only be accessed by investigators participating in this larger study and by no one outside of this larger study.
IPD Sharing Time Frame
The data will become available by March 10, 2018.
It will be available for 4 years.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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