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Pneumonia | Operational Research Management for Children With Severe Pneumonia

Pneumonia research study

What is the primary objective of this study?

The investigators Study Hypothesis is introduction of modified IMCI guideline for managing severe pneumonia in first level health facilities will result in 40% increase in the appropriate management (appropriate case management at the first level facility and referral compliance by the caregivers) of severe pneumonia cases in the intervention arm compared to the comparison arm.

Who is eligible to participate?

Inclusion Criteria: - Severe pneumonia with patients of 2 months to 5 years - Attending first level health care facilities - In Selected study areas Exclusion Criteria: - Any other categories of pneumonia other than severe pneumonia.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pneumonia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Amoxycilline, Cephradine followed by follow up on day 3Modified IMCI Guideline for treating severe phnemonia will be implemented in the arm 1. The Modified IMCI guideline denotes that all severe pneumonia cases with only chest indrawing and no other danger signs will be treated at the first level health facilities with first line oral antibiotics followed by follow-up on 3rd day. On 3rd day the patient will be reassessed and if the condition improves the first line antiobiotic will be continued and if deteriorates or remain unchange second line antibiotic will be used. The patient will be further asked to come on day 3 for reassessment.

Other:Injectable ampicillin followed by urgent referralExisting IMCI guideline denotes all severe pneumonia cases will be referred to the 1st level referral facilities after giving first dose of injectable antibiotics

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Modified IMCI guidelineModified IMCI Guideline for treating severe phnemonia will be implemented in the arm 1. The Modified IMCI guideline denotes that all severe pneumonia cases with only chest indrawing and no other danger signs will be treated at the first level health facilities with first line oral antibiotics followed by follow-up on 3rd day. On 3rd day the patient will be reassessed and if the condition improves the first line antiobiotic will be continued and if deteriorates or remain unchange second line antibiotic will be used. The patient will be further asked to come on day 3 for reassessment.

Current IMCI guidelineExisting IMCI guideline denotes all severe pneumonia cases will be referred to the 1st level referral facilities after giving first dose of injectable antibiotics

Study Status

Completed

Start Date: August 2010

Completed Date: December 2013

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Proportion of Severe Pneumonia cases approapriately treated as per the Modified IMCI guideline

Secondary Outcome: Proportion of childhood pneumonia cases treated by trained service provider

Study sponsors, principal investigator, and references

Principal Investigator: Shams EL Arifeen, MBBS, DrPH

Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborator: UNICEF

More information:https://clinicaltrials.gov/show/NCT01312792

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