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.

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.

• Authors: Victoria Nankabirwa, Thorkild Tylleskär, Josephine Tumuhamye, James K Tumwine, Grace Ndeezi, José C Martines, Halvor Sommerfelt
• Journal: Trials (Trials) Vol. 18 Issue 1 Pg. 322 (07 12 2017) ISSN: 1745-6215 [Electronic] England
• PMID: 28701228 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Infective Agents, Local
• Chlorhexidine

Topics

• Administration, Topical
• Anti-Infective Agents, Local (administration & dosage, adverse effects)
• Bacterial Infections (diagnosis, microbiology, prevention & control)
• Chlorhexidine (administration & dosage, adverse effects)
• Clinical Protocols
• Communicable Disease Control (methods)
• Female
• Humans
• Infant, Newborn
• Infant, Newborn, Diseases (diagnosis, microbiology, prevention & control)
• Pregnancy
• Research Design
• Risk Factors
• Time Factors
• Treatment Outcome
• Uganda
• Umbilical Cord (drug effects, microbiology, surgery)