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

00003027

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.

2011-05-19

2014-09-29

2014-09-29

Completed

Early phase I

36911

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 36911, 'type': 'ACTUAL'}}

2023-08-28