PneumoniaNCT03260413
Pneumonia Chart Review Cambodia
An observational study of Pneumonia, run by University of Minnesota.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Pneumonia
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 12 Feb 2018to 9 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Children who do not fall into the aforementioned age range and who do not have "pneumonia" or "bronchiolitis" as one of the admitted diagnoses.
About this study
Official title: 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.
- Conditions
- Pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Pneumonia count
Number of admissions for pneumonia to Chenla Children's healthcare
Measured: 5-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start12 Feb 2018 (estimated)
- Primary completion9 Mar 2018 (estimated)
- Study completion9 Mar 2018 (estimated)
Why it stopped: Could not get IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260413
- Sponsor's protocol ID
- STUDY00000091
- Status last verified
- Mar 2018
- First submitted
- 21 Aug 2017
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying the Burden of Hospitalizations for Pneumonia Among Children in Rural
- ClinicalTrials.gov ID
- NCT03260413
- Acronym / sponsor ID
- STUDY00000091
- Conditions
- Pneumonia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Could not get IRB approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 12 Feb 2018 (estimated)
- Primary completion
- 9 Mar 2018 (estimated)
- Study completion
- 9 Mar 2018 (estimated)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Children who do not fall into the aforementioned age range and who do not have "pneumonia" or "bronchiolitis" as one of the admitted diagnoses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pneumonia count
Time frame: 5-6 months
Number of admissions for pneumonia to Chenla Children's healthcare
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumonia count (time frame: 5-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018; AzTrials last refreshed its copy on 30 Oct 2026.