Impact of Umbilical Cord Cleansing With 4.0% Chlorhexidine on Neonatal Mortality (CHX)

October 3, 2022 updated by: Johns Hopkins Bloomberg School of Public Health

Impact of Umbilical Cord Cleansing With Chlorhexidine on Neonatal Mortality and Omphalitis in Rural Sylhet District of Bangladesh

A community based trial that seeks to address the effect of umbilical cord cleansing using 4.0% chlorhexidine cleansing solution

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Of the annual four million neonatal deaths, 99% occur in developing countries, and more than one-third globally can be attributed to infections. In areas with high-mortality rates, the proportion attributable to infections is as high as 50%. Many infections in infants can be prevented or treated with already existing measures, yet finding the best way to provide these measures in communities that are limited in resources need to be identified. Applying chlorhexidine to the umbilical cord of newborns may be a simple way to help reduce neonatal mortality and morbidity in the community at low cost.

A study by our group was recently completed in Nepal. It was a large community-based, factorial-designed trial in southern Nepal to: (1) assess the impact of newborn total body skin cleansing with 0.25% chlorhexidine on neonatal mortality and morbidity and (2) assess the impact of cleansing of the umbilical stump with 4% chlorhexidine on omphalitis and neonatal mortality.

The results of these studies have suggested that chlorhexidine antisepsis interventions may significantly reduce neonatal mortality and omphalitis. A single full body cleansing of the neonate with chlorhexidine as soon as possible after birth reduced mortality among low birth weight (LBW) infants by 28%. Repeated cleansing of the umbilical stump with chlorhexidine reduced the rate of severe cord infection by 75% and, if this treatment was begun within the first 24 hours following birth, reduced neonatal mortality by 34%.

In rural Bangladesh, over 90% of women deliver at home with only untrained local women or family members in attendance, and low birth weight babies are delivered approximately 30% of the time. The overall neonatal mortality rate exceeds 36 per 1000 live births and in order to reduce this burden, simple, cost-effective interventions that can be delivered at the community level are urgently needed. Given the potential impact of repeated chlorhexidine cleansing of the cord demonstrated in the Nepal trial, a replication study of this regimen and further investigations of more simple regimens are necessary. The number of treatments necessary to reduce neonatal mortality has important programmatic implications for who can deliver the intervention, and how it is packaged.

Study Type

Interventional

Enrollment (Anticipated)

28797

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Sylhet, Bangladesh
        • Rural Sylhet District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • live-born infants delivered in one of three upazillas of Sylhet District (Zakiganj, Khanaighat, Beanibazar)
  • married women of reproductive age within their individual target areas listed above

Exclusion Criteria:

  • individuals outside of the target area in Sylhet(Zakiganj, Khanaighat, Beanibazar)
  • infants not met at home by a project worker during the first seven days of life

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
4.0% chlorhexidine cleansing of the cord during home visits by project workers for the first 7 days after birth
Behavioral: CHX x 7 days
4.0% chlorhexidine cleansing of the cord during home visits by project workers for the first 7 days after birth
Experimental: 2
4.0% chlorhexidine cleansing of the cord applied once by a project worker visiting the newborn in the home as soon as possible after birth
Behavioral: chx once
4.0% chlorhexidine cleansing of the cord applied once by a project worker visiting the newborn in the home as soon as possible after birth
Active Comparator: 3
dry cord care
Behavioral: dry cord care
Household members are instructed to apply nothing to the newborn's umbilical cord stump.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
neonatal mortality
Time Frame: 3 Month intervals
3 Month intervals
omphalitis among live born infants.
Time Frame: 3 Month intervals
3 Month intervals

Secondary Outcome Measures

Outcome Measure
Time Frame
newborn care practices
Time Frame: 3 Years
3 Years
care seeking behaviors
Time Frame: 3 Years
3 Years
morbidity measures, including sepsis and omphalitis
Time Frame: 3 Years
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh
Government of Bangladesh
Save the Children
Shimantik

Investigators

  • Principal Investigator: Abdullah H Baqui, MBBS, DrPH, Johns Hopkins Bloomberg School of Public Health
  • Principal Investigator: Shams El Arifeen, International Centre for Diarrhoeal Disease Research, Bangladesh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

February 9, 2007

First Submitted That Met QC Criteria

February 9, 2007

First Posted (Estimate)

February 13, 2007

Study Record Updates

Last Update Posted (Actual)

October 5, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00000146
  • GHSA00030001900 (Other Grant/Funding Number: Save the Children 131)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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