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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Makerere University
Sponsor:
Collaborator:
Centre For International Health
Information provided by (Responsible Party):
Makerere University
ClinicalTrials.gov Identifier:
NCT02606565
First received: November 12, 2015
Last updated: January 4, 2017
Last verified: January 2017
  Purpose

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.


Condition Intervention Phase
Omphalitis Septicaemia Biological: Intervention arm: 4% chlorhexidine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Makerere University:

Primary Outcome Measures:
  • Proportion of infants with severe illness [ Time Frame: First 28 days of life ]
    Severe illness will be defined as illness that is associated with any of the following danger signs observed or verified by a study clinician: inability to feed or vomiting of everything and unable to keep anything down, lethargy or unconsciousness, severe lower chest in-drawing, axillary temperature of ≥37.5 degrees Celsius or <35.5 degrees Celsius, grunting, cyanosis, convulsions or a history of convulsions, and/or results in hospitalization and/or results in death. Hospitalization and death resulting from violent injury or burns will not contribute to the severe illness definition.

  • Proportion of infants with omphalitis [ Time Frame: First 28 days of life ]
    This outcome will be recorded as present or absent based on specific signs. These include: pus, redness (inflammation) and swelling (oedema) of the cord stump and the surrounding skin at its base. Swelling and redness will be further broken down into: none, mild, moderate and severe. No swelling or redness will be the absence of visible swelling or redness; mild swelling or redness as that limited to the cord stump only; moderate swelling or redness as that extending less than 2cm onto the abdominal skin at the base of the stump and severe swelling or redness as extending ≥2cm into the abdominal skin at the base of the stump. Pus will be defined as either present or absent. Cord infection will then be defined based on combinations of these recorded signs and their severity into four categories as follows: 1) redness extending to skin or pus, 2) moderate or severe redness, 3) moderate or severe redness with pus, or severe redness alone and 4) Severe redness with pus.


Secondary Outcome Measures:
  • Death [ Time Frame: First 28 days of life ]
  • Adverse events [ Time Frame: First 28 days of life ]

Estimated Enrollment: 4760
Study Start Date: July 2016
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Biological: Intervention arm: 4% chlorhexidine
See previous description
No Intervention: Control arm: Dry cord care
Neonates randomized to the control arm will receive the current standard of cord care (dry cord care)

  Eligibility

Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Newborns weighing 1.5kg or more at birth

Exclusion Criteria:

  • Newborns with severe congenital anomalies
  • Newborns with infection of the umbilical cord at birth
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02606565

Contacts
Contact: Victoria Nankabirwa, MD, MPH, PhD +256755757460 nankabirwav@gmail.com
Contact: Josephine Tumuhamye +256702063261 tphynne@gmail.com

Locations
Uganda
Health Centers in Mukono and Kampala districts Recruiting
Kampala, Uganda
Contact: Victoria Nankabirwa, MBChB, MPH, PhD    +256755757460    nankabirwav@gmail.com   
Contact: Josephine Tumuhamye, BBLT, MICM    0702063261    tphynne@gmail.com   
Principal Investigator: Victoria Nankabirwa, PhD         
Principal Investigator: Halvor Sommerfelt, PhD         
Sub-Investigator: Grace Ndeezi, PhD         
Sub-Investigator: James Tumwine, PhD         
Sub-Investigator: Thorkild Tylleskar, PhD         
Sponsors and Collaborators
Makerere University
Centre For International Health
Investigators
Principal Investigator: Victoria Nankabirwa, MD, MPH, PhD Department of Epidemiology and Biostatistics, School of Public Health, College of Health Sciences, Makerere University
  More Information

Publications:
Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT02606565     History of Changes
Other Study ID Numbers: 2015-118
Study First Received: November 12, 2015
Last Updated: January 4, 2017

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on June 27, 2017