Clinical trial NCT02606565: Efficacy of Umbilical Cord Cleansing With a Single Application of 4% Chlorhexidine for the Prevention of Newborn Infections in Uganda: a Randomized Controlled Trial
Official title: Acceptability and Efficacy of Umbilical Cord Cleansing With 4% Chlorhexidine for the Prevention of Newborn Infections in Lira District, Northern Uganda: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Omphalitis
Septicaemia
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: Centre For International Health
First posted: 2015-11-17
Enrollment: 4760
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of infants with severe illness
timeFrame: First 28 days of life
measure: Proportion of infants with omphalitis
timeFrame: First 28 days of life
Secondary outcomes:
measure: Death
timeFrame: First 28 days of life
measure: Adverse events
timeFrame: First 28 days of life
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Health Centers in Mukono and Kampala districts
Study officials:
affiliation: Department of Epidemiology and Biostatistics, School of Public Health, College of Health Sciences, Makerere University
name: Victoria Nankabirwa, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Imdad A, Bautista RM, Senen KA, Uy ME, Mantaring JB 3rd, Bhutta ZA. Umbilical cord antiseptics for preventing sepsis and death among newborns. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD008635. doi: 10.1002/14651858.CD008635.pub2.
citation: Nankabirwa V, Tylleskar T, Tumuhamye J, Tumwine JK, Ndeezi G, Martines JC, Sommerfelt H. 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. Trials. 2017 Jul 12;18(1):322. doi: 10.1186/s13063-017-2050-0.