Abstract
BackgroundYearly, nearly all the estimated worldwide 2.7 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 neonates with omphalitis than in those without. Five large randomized controlled trials in Asia and Sub-Saharan Africa (SSA) have examined the effect of multiple cord stump applications with 4% chlorhexidine (CHX) for at least 7 days on the risk of omphalitis and neonatal death. These studies, all community-based, show that multiple CHX applications reduced the risk of omphalitis. Of these trials, only one study from South Asia (the Bangladeshi study) and none from Africa examined the effect of a single application of CHX as soon as possible after birth. In this Bangladeshi trial, 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 among health-facility births. A single application is programmatically much simpler to implement than daily applications for 7 days. Therefore, our study compares umbilical cord cleansing with a single application of 4% CHX at birth with dry cord care among Ugandan babies born in health facilities, on the risk of omphalitis and severe neonatal illness.MethodsThe CHX study is a facility-based, individually randomized controlled trial that will be conducted among 4760 newborns in Uganda. The primary outcomes are severe illness and omphalitis during the neonatal period. Analysis will be by intention-to-treat.DiscussionThis study will provide novel evidence, from a Sub-Saharan African setting, of the effect of umbilical cord cleansing with a single application of 4% CHX at birth and identify modifiable risk factors for omphalitis.Trial registrationClinicalTrials.gov, identifier: NCT02606565. Registered on 12 November 2015.
Highlights
Most the estimated worldwide 2.7 million neonatal deaths occur in low- and middle-income countries
We found five published reports of large randomized trials, all communitybased, that have been done in low- and middle-income countries (LMICs); three in Asia and two in Sub-Saharan Africa (SSA) [6–10]
Results of the effect of 4% CHX applied to the umbilical cord stump on neonatal mortality in the three Asian trials are incongruent with findings in the two African trials
Summary
The current situation in which approximately 2.7 million children, mostly in LMICs, die within 28 days of birth is unconscionable. Sometimes daily, CHX applications and study visits by community health workers, the likelihood of obtaining a null finding because of this effect with a mortality outcome cannot be overlooked This is so in settings where frequent study visits have a high likelihood of coinciding with severe illness events which, in turn, result in interventions by the study team that likely lead to a reduction in mortality for all study arms. This study is of high relevance and benefit to societies in SSA where it will yield novel information because the effect of a single topical application of 4% CHX in birth facilities has not been studied, and where awareness and demand of this potentially life-saving intervention is nearly nonexistent among women, caregivers and health practitioners.
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