Operational Research Management for Children With Severe Pneumonia

NCT01312792 | Completed DMC

• 1 other identifier: PR-10025
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumonia

Keywords

Severe Pneumonia; Pneumonia; ARI; IMCI; Modified IMCI; 1st level Health facilities; Children; Operational Research; Bangladesh; Treatment of Severe Pneumonia

Outcome Measures

Primary Outcomes (2)

• Proportion of Severe Pneumonia cases approapriately treated as per the Modified IMCI guideline

  Appropriate management as per modified IMCI guideline denotes Severe pneumonia cases with only chest indrawing and no other danger signs. Such cases will be managed by 1st line oral antiobiotic Amoxicillin by the 1st level health providers. The patient will be asked to come back on 3rd day for follow up when he will be reasessed. If condition improves the antibiotic will be continued for 5 days and if condition deteriorates or remain unchange second line antiobiotic Cephradine will be used. During the treatment if any danger sign appear at any stage the patient will be immediately referred.

  15 months

• Proportion of severe pneumonia cases complied appropriately with followup advice given by the health care providers

  Severe pneumonia cases with only chest indrawing and no other danger signs will be managed by 1st level health providers. In this study the appropriate maangement denotes both treatment with antibiotics and complying with the followup advice given by the health care provider. Following antibiotic prescription, the patient will be asked to come back on 3rd day for follow up when S/he will be reasessed. This is an integral part of the modified IMCI guideline.

  15 months

Secondary Outcomes (1)

• Proportion of childhood pneumonia cases treated by trained service provider

  15 months

Study Arms (2)

Modified IMCI guideline

EXPERIMENTAL

Modified 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: Amoxycilline, Cephradine followed by follow up on day 3

Current IMCI guideline

ACTIVE COMPARATOR

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

Other: Injectable ampicillin followed by urgent referral

Interventions

Amoxycilline, Cephradine followed by follow up on day 3 OTHER

Modified 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.

Also known as: Fimoxyl

Modified IMCI guideline

Injectable ampicillin followed by urgent referral OTHER

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

Also known as: Ficillin, ampicillin

Current IMCI guideline

Eligibility Criteria

• Age: 2 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Severe pneumonia with patients of 2 months to 5 years
• Attending first level health care facilities
• In Selected study areas

You may not qualify if:

• Any other categories of pneumonia other than severe pneumonia.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• UNICEF: collaborator

Study Sites (1)

Union health facility

Gopālganj, Gopalganj, 8131, Bangladesh

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Ampicillin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Shams EL Arifeen, MBBS, DrPH

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 11, 2011
• Study Start: August 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

BA (1)