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

• Status: Terminated
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aga Khan University
• Treatments: Amoxicillin

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