NCT03260413

Brief 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, Cambodia. This will involve a chart review of the medical records available at Chenla Children's Healthcare.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

February 12, 2018

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2018

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

25 days

First QC Date

August 21, 2017

Last Update Submit

March 23, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pneumonia count

    Number of admissions for pneumonia to Chenla Children's healthcare

    5-6 months

Study Arms (1)

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.

Eligibility Criteria

Age1 Month - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Children who do not fall into the aforementioned age range and who do not have "pneumonia" or "bronchiolitis" as one of the admitted diagnoses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2017

First Posted

August 24, 2017

Study Start

February 12, 2018

Primary Completion

March 9, 2018

Study Completion

March 9, 2018

Last Updated

March 27, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, CSR, ANALYTIC CODE
Time Frame
The data will become available by March 10, 2018. It will be available for 4 years.