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

NCT ID: NCT02606565

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 4760 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2020-10-01

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.

Conditions

Omphalitis; Septicaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention arm: 4% chlorhexidine

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

Group Type: EXPERIMENTAL

Intervention arm: 4% chlorhexidine

Intervention Type: BIOLOGICAL

See previous description

Control arm: Dry cord care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intervention arm: 4% chlorhexidine

See previous description

Intervention Type: BIOLOGICAL

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

• Maximum Eligible Age: 2 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre For International Health

OTHER

Sponsor Role: collaborator

Makerere University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victoria Nankabirwa, MD, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Epidemiology and Biostatistics, School of Public Health, College of Health Sciences, Makerere University

Locations

Health Centers in Mukono and Kampala districts

Kampala, , Uganda

Countries

Uganda

References

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.

Reference Type: RESULT

PMID: 23728678 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28701228 (View on PubMed)

Other Identifiers

2015-118

Identifier Type: -

Identifier Source: org_study_id