Neonatal Mortality Clinical Trial
— CHX-PembaOfficial title:
Efficacy of Use of Chlorhexidine to Clean Umbilical Cord of Neonates in First 10 Days for Reduction in Neonatal Mortality and Omphalitis - A Community Based Randomized, Double Masked Controlled Trial in Pemba Tanzania
Verified date | August 2023 |
Source | Johns Hopkins Bloomberg School of Public Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In a community-based controlled trial among children to evaluate if use of 4% Chlorhexidine cleansing solution on umbilical cord of infants in first 10 days of life results in - Reduction in neonatal mortality (deaths in first 28 days of life) - Reduction in umbilical cord infections (defined by moderate or severe redness of the cord) during first 28 days of life - Reduction in umbilical cord infections (defined by pus formation with any degree of redness) during first 28 days of life. The double blind part of study uses a control preparation without chlorhexidine (CHX) as control group while in the sub-study dry cord care group is also evaluated as second control. Hypothesis is that CHX group will have lower mortality and umbilical cord infections while control group and dry cord group will be similar as shown in a previous study in Nepal.
Status | Completed |
Enrollment | 36911 |
Est. completion date | September 29, 2014 |
Est. primary completion date | September 29, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Hour to 48 Hours |
Eligibility | Inclusion Criteria: - Permanent resident of Pemba - Consenting to participate, infants alive at first contact with MCH/TBA/Hospital staff - First contact within 48 hours of delivery. Exclusion Criteria: - Congenital malformations where application of intervention is not possible - Very sick child needing hospitalization and ICU care. |
Country | Name | City | State |
---|---|---|---|
Tanzania | PHL-IDC | Pemba | Zanzibar |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins Bloomberg School of Public Health | Annamalai University, Bill and Melinda Gates Foundation, Ministry of Health and Social Welfare, Zanzibar |
Tanzania,
Sazawal S, Dhingra U, Ali SM, Dutta A, Deb S, Ame SM, Mkasha MH, Yadav A, Black RE. Efficacy of chlorhexidine application to umbilical cord on neonatal mortality in Pemba, Tanzania: a community-based randomised controlled trial. Lancet Glob Health. 2016 N — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neonatal Mortality | 28 days after birth | ||
Secondary | Omphalitis | Using two field based definitions presence of redness or swelling with or without PUS. | Birth to 28 days of life |
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