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Principal Investigator: Dr Victoria Nankabirwa

Funder: Globvac Research Council of Norway

Dr Nankabirwa won a young investigator award to conduct a randomized controlled trial examining the effect of umbilical cord cleansing  with 4% chlorhrxidine, an antiseptic, on omphalitis, septicaemia and neonatal mortality.

Annually, 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 to moderate omphalitis and neonatal death. It is important in the African setting to explore the effect of a single application among health-facility births. A sinlge application is programmatically much easier to implement than daily applications for 7 days.

The Ugandan CHX study compares umbilical cord cleansing with a single application of 4% CHX at birth and thereafter dry cord care among Ugandan babies born in health facilities that ate at the risk of omphalitis and severe neonatal illness. The 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.

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% CHX at birth and identify modifiable risk factors for omphalitis.

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