Omphalitis Clinical Trial
Official title:
Acceptability and Efficacy of Umbilical Cord Cleansing With 4% Chlorhexidine for the Prevention of Newborn Infections in Lira District, Northern Uganda: A Randomised Controlled Trial
Background: Nearly all the yearly 3.3 million neonatal deaths occur in low and middle income
countries. Infections, including those affecting the umbilical cord (omphalitis) are a
significant factor in approximately a third of these deaths. In fact, the odds of all-cause
mortality are 46% higher among infants with umbilical cord infection than those without
infection. Five large randomized controlled trials in Asia and Sub-Saharan Africa have
examined the effect of multiple applications (for at least 7 days) of 4% chlorhexidine (CHX)
on the umbilical cord on omphalitis and neonatal death. These studies show a consitent
positive effect of multiple applications on omphalitis but not on neonatal mortality. Whereas
there is mounting evidence for the effect of 7 day chlorhexidine application, there is no
data from Africa and only one study from Asia that examines the effect of a single
application of CHX as soon as possible after birth. In this single Asian study, CHX led to a
reduction in the risk of mild-moderate omphalitis and neonatal death. It is important, in an
African setting to explore the effect of a single application, which is programmatically much
simpler to implement than daily application for 7 days. Therefore, the investigators' study
will compare umbilical cord cleansing with a single application of 4% chlorhexidine at birth
with dry cord care in both community and facility births on omphalitis and severe illness in
the neonatal period.
Methods: The chlorhexidine study is a community based, individually randomised controlled
trial conducted on 4,760 mother-infant pairs in Uganda. The primary outcomes are severe
illness and umbilical cord infection (omphalitis). Severe illness is defined as any illness
associated with at least one of the following danger signs observed by study research
assistants: inability to drink or breastfeed or (a history of) convulsions, lethargy or
unconsciousness, vomiting of all feeds, and/or results in hospitalization and/or results in
death.
Discussion: This study will provide novel evidence, from a Sub-Saharan African setting of the
effect of umbilical cord cleansing with a single application of 4% chlorhexidine at birth in
both community and facility births.
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