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

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

Detailed Description
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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.

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

Conditions
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Omphalitis, Infection

Intervention / Treatment
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* Behavioral: chx once
* Behavioral: CHX x 7 days
* Behavioral: dry cord care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* 4.0% chlorhexidine cleansing of the cord during home visits by project workers for the first 7 days after birth<br>|
| Experimental: 2<br>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<br>* 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<br>|
| Active Comparator: 3<br>dry cord care | Behavioral: dry cord care<br>* Household members are instructed to apply nothing to the newborn's umbilical cord stump.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neonatal mortality |  | 3 Month intervals | 
| omphalitis among live born infants. |  | 3 Month intervals | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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omphalitis, neonates, umbilical cord, infection, infant mortality, neonate morbidity, chlorhexidine