Community Based Management of Fast Breathing in Infants Aged < 60 Days in Low-income Settlements of Karachi (MAT-YI)
June 2, 2014 updated by: Shiyam Sunder Tikmani, Aga Khan University
Community Based Management of Fast Breathing in Infants Aged < 60 Days: A Double-Blind, Randomized Placebo-Controlled Trial in Low-income Settlements of Karachi
The aim of the study is to determine optimal management of isolated fast breathing in young infants in a trial design conducted in primary care settings.
The investigators hypothesized that proportion of infants who fail therapy will be 4% in each group. A 6% or less difference in failure rate will be considered equivalent.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The management of isolated fast breathing is therefore unknown and our experience suggests that these infants could perhaps be managed without antibiotics.
Widespread application of the WHO clinical algorithm could therefore result in the referral of as many as 13.7% (135.7 per 1000 live births) of all infants for isolated fast breathing, the vast majority of these unnecessarily, and exposing infants to a high risk of nosocomial sepsis and hospital mortality in addition to over-burdening health resources.
Study Type
Interventional
Enrollment (Actual)
963
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sind
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Karachi, Sind, Pakistan, 74800
- Primary Health Centers
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-
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
No older than 1 month (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- Young infant (0-59 days of age)
- Fast breathing i.e., respiratory rate ≥60 breaths/min
- O2 Saturation ≥90%
- Resident of catchment area (to ensure complaint and follow up)
- Refused hospitalization and investigations
- Informed consent is provided by a parent (or legal guardian).
Exclusion Criteria:
- Preterm infants (born <37 weeks)
- Presence of audible murmur
- Any concurrent signs of severe infection:
- not feeding well
- movement only when stimulated
- severe chest in-drawing
- axillary temperature ≥38.0oC or ≤35.5oC
- Any sign of being critically ill (Cyanosis, bulging fontanel, unable to feed, unable to cry, apnoea, convulsions, unconscious, persistent vomiting)
- Weight <1800gm at the time of presentation
- Major congenital malformations or suspected chromosomal abnormalities
- Hospitalization for illness in the last two weeks
- Previous inclusion in the study
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Sugar Syrup
|
It will be given 2 times/day for 7 days
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Active Comparator: Amoxicillin
This is an active intervention
|
80-100 mg/kg/day in 2 divided doses for 7 days For convenience dose divided into six weight bands Table 2: Dose of amoxicillin Weight band Amount per dose Daily dose Lower Limit (mg or units /kg/d) Upper Limit (mg or units /kg/d) Amoxicillin - desired range 75-100 mg/kg/day (25mg/ml (125mg/5ml); twice daily orally)* 1.8-1.9 kg 3.0 ml 150 mg 75.4 100.0 2.0-2.4 kg 4.0 ml 200 mg 80.3 100.0 2.5-2.9 kg 5.0 ml 250 mg 83.6 100.0 3.0-3.9 kg 6.0 ml 300 mg 75.2 100.0 4.0-4.9 kg 8.0 ml 400 mg 80.2 100.0 5.0-5.9 kg 10.0 ml 500 mg 83.5 100.0 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment failure
Time Frame: Day 8 of enrollemnt
|
|
Day 8 of enrollemnt
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compliance to treatment
Time Frame: 80% of total dosage
|
To label as per protocol infant should receive 100% (4 doses) of doses in first 2 days followed by 70% (7 doses) of doses from day 3 to day 8.
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80% of total dosage
|
|
Proportion of infants relapse
Time Frame: No treatment failure by day 8 and signs of sepsis or fast breathing between day 8-14
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No treatment failure by day 8 and signs of sepsis or fast breathing between day 8-14
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shiyam Sunder P Tikmani, MBBS, Aga Khan University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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
May 1, 2012
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
February 13, 2012
First Submitted That Met QC Criteria
February 14, 2012
First Posted (Estimate)
February 15, 2012
Study Record Updates
Last Update Posted (Estimate)
June 3, 2014
Last Update Submitted That Met QC Criteria
June 2, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1979-CHS-ERC-11
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