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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00434408
Acronym
CHX
Enrollment
28797
Registered
2007-02-13
Start date
2007-05-31
Completion date
2010-11-30
Last updated
2022-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Omphalitis

Keywords

omphalitis, neonates, umbilical cord, infection, infant mortality, neonate morbidity, chlorhexidine

Brief summary

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

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.

Interventions

BEHAVIORALchx 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

BEHAVIORALCHX x 7 days

4.0% chlorhexidine cleansing of the cord during home visits by project workers for the first 7 days after birth

BEHAVIORALdry cord care

Household members are instructed to apply nothing to the newborn's umbilical cord stump.

Sponsors

Government of Bangladesh
CollaboratorOTHER_GOV
International Centre for Diarrhoeal Disease Research, Bangladesh
CollaboratorOTHER
Save the Children
CollaboratorOTHER
Shimantik
CollaboratorUNKNOWN
Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 7 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
neonatal mortality3 Month intervals
omphalitis among live born infants.3 Month intervals

Secondary

MeasureTime frame
newborn care practices3 Years
care seeking behaviors3 Years
morbidity measures, including sepsis and omphalitis3 Years

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026