1. Efficacy of umbilical cord cleansing with a single application of 4% chlorhexidine for the prevention of newborn infections in Uganda: study protocol for a randomized controlled trial.
- Author
-
Nankabirwa, Victoria, Tylleskär, Thorkild, Tumuhamye, Josephine, Tumwine, James K., Ndeezi, Grace, Martines, José C., and Sommerfelt, Halvor
- Subjects
CHLORHEXIDINE ,UMBILICAL cord diseases ,NEONATAL infections ,NEONATAL death ,OMPHALITIS ,PUBLIC health ,PREVENTION ,DIAGNOSIS of bacterial diseases ,BACTERIAL disease prevention ,DIAGNOSIS of neonatal diseases ,BACTERIAL diseases ,BACTERICIDES ,PREVENTION of communicable diseases ,COMPARATIVE studies ,EXPERIMENTAL design ,NEONATAL diseases ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH protocols ,RESEARCH ,CUTANEOUS therapeutics ,TIME ,EVALUATION research ,UMBILICAL cord ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,SURGERY - Abstract
Background: Yearly, 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.Methods: 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.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% CHX at birth and identify modifiable risk factors for omphalitis.Trial Registration: ClinicalTrials.gov, identifier: NCT02606565 . Registered on 12 November 2015. [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF