Efficacy of Umbilical Cord Cleansing With a Single Application of 4% Chlorhexidine for the Prevention of Newborn Infections in Uganda: a Randomized Controlled Trial

Makerere University

Status and phase: Completed; Phase 4

Conditions: Omphalitis; Septicaemia

Treatments: Biological: Intervention arm: 4% chlorhexidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02606565

2015-118

Details and patient eligibility

About

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.

Enrollment: 4,760 patients

Sex: All

Ages: Under 2 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Newborns weighing 1.5kg or more at birth
• Newborns born to mothers whose HIV I status is negative

Exclusion criteria

• Newborns with severe congenital anomalies
• Newborns with infection of the umbilical cord at birth
• Twins or triplets
• Severely ill infants requiring hospitalization immediately after birth
• Children of mothers who cannot appropriately give consent within 12 h of birth

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,760 participants in 2 patient groups

Intervention arm: 4% chlorhexidine

Experimental group

Description:

Neonates randomized to the chlorhexidine arm will have umbilical stump cleansing with a single application of 4% chlorhexidine solution at birth

Treatment:

Biological: Intervention arm: 4% chlorhexidine

Control arm: Dry cord care

No Intervention group

Description:

Neonates randomized to the control arm will receive the current standard of cord care (dry cord care)