Community Based Management of Fast Breathing in Infants Aged < 60 Days in Low-income Settlements of Karachi (MAT-YI)

Aga Khan University

Status and phase: Terminated; Phase 4

Conditions: Fast Breathing in Young Infants

Treatments: Drug: Amoxicillin; Drug: Sugar Syrup

Study type: Interventional

Funder types: Other

Identifiers

NCT01533818

1979-CHS-ERC-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 963 patients

Sex: All

Ages: Under 59 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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963 participants in 2 patient groups, including a placebo group

Amoxicillin

Active Comparator group

Description:

This is an active intervention

Treatment:

Drug: Amoxicillin

Sugar Syrup

Placebo Comparator group

Treatment:

Drug: Sugar Syrup