Title

Community based management of fast breathing infants aged <60 days : a double-blind, randomized placebo-controlled trial in low income settlements of Karachi

Date of Award

2014

Document Type

Thesis

Degree Name

Master of Science in Epidemiology & Biostatistics (MSc Epidemiology & Biostats)

Department

Community Health Sciences

Abstract

According to WHO, infants presented with fast breathing (RR>=60) should be considered of hospital referral. However, due to the high prevalence of fast breathing, referral may increase the burden on tertiary care hospital as well as source nosocomial infections. In our observational cohort, infants with isolated fast breathing can be managed at home without antibiotics. The purpose of the study is to determine strategies for optimal treatment of isolated fast breathing in young infants in a trial design conducted in primary care settings. Objective: To assess if 7 day's treatment of oral amoxicillin is equivalent to placebo in young infants with fast breathing in out-patient setup. Methods: This double blind randomized placebo controlled trial was conducted at community setting run by the Department of Paediatrics Aga Khan University, Karachi, Pakistan. Infants of <60 days, who have been diagnosed with isolated fast breathing (RR>=60 b/min) and oxygen saturation of >=90% were determined for eligibility. After informed consent treatment was assigned through the serial number. Randomization was taking place at clinical trial unit, Aga Khan University. Each enrolled infant were followed daily for 7 days by community health workers except on day 3 and 8 when the infant was seen by a doctor, and on days 11 and le of enrollment. The primary outcome was treatment failure. The data was recorded in case report forms. The trial was stopped based on DSMB recommendations. Results: There were no significant differences in proportion of treatment failure in placebo vs. amoxicillin arm. Overall 37 infants failed treatment by day 7 [25 (5.9%) placebo arm and 12 (2.8%) to Amoxicillin arm]. The difference of proportion of treatment failure was (RD 3.1, 95% CI: 0.3, 5.8). The proportions of adverse events are similar across the group except two deaths which were in placebo arm only. The proportion of relapse is evenly distributed across treatment arms. Conclusion: In the results of this study, we conclude that the benefit of antibiotics in young infants with isolated fast breathing should be treated with oral antibiotics. There is a need to revise the WHO guidelines on management of isolated fast breathing.

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