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

This study has been completed.
Sponsor:
Collaborators:
Government of Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh
Save the Children
Shimantik
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00434408
First received: February 9, 2007
Last updated: August 9, 2011
Last verified: July 2007
  Purpose

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


Condition Intervention Phase
Omphalitis
Infection
Behavioral: chx once
Behavioral: CHX x 7 days
Behavioral: dry cord care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of Umbilical Cord Cleansing With Chlorhexidine on Neonatal Mortality and Omphalitis in Rural Sylhet District of Bangladesh

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • neonatal mortality [ Time Frame: 3 Month intervals ] [ Designated as safety issue: No ]
  • omphalitis among live born infants. [ Time Frame: 3 Month intervals ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • newborn care practices [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
  • care seeking behaviors [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
  • morbidity measures, including sepsis and omphalitis [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 28797
Study Start Date: May 2007
Study Completion Date: November 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00434408

Locations
Bangladesh
Rural Sylhet District
Sylhet, Bangladesh
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Government of Bangladesh
International Centre for Diarrhoeal Disease Research, 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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Abdullah H. Baqui, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00434408     History of Changes
Other Study ID Numbers: IRB00000146, GHSA00030001900
Study First Received: February 9, 2007
Last Updated: August 9, 2011
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
omphalitis
neonates
umbilical cord
infection
infant mortality
neonate morbidity
chlorhexidine

Additional relevant MeSH terms:
Infection
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on September 16, 2014