Chlorhexidine Cordcare for Reduction in Neonatal Mortality and Omphalitis

Study Overview
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Brief Summary
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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.

Detailed Description
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Project Goal: The purpose of the trial is to evaluate the efficacy of cord cleansing with Chlorhexidine in the first 10 days of life in reducing neonatal mortality and morbidity. The study would provide a proof of principle for an intervention that could easily be scaled up. Objectives of formative phase: Using TIPS (Trials of Improved Practices) methodology to evaluate the acceptance and impediments if any to practice of using liquid solution for cord cleaning including washing of hands with soap before and after use. To compare 3 modes (3 different packaging with application using cotton ball, dropper bottle and squeeze tube) of delivery for cord cleaning in terms of acceptance, ease of use and effectiveness in covering the target area. Objectives of the main Trial : Primary Objectives: In a double-blind community-based randomized controlled trial among 24,000 children to evaluate the efficacy of application of 4% Chlorhexidine cleansing solution on umbilical cord of infants in first 10 days of life compared to infants cleansed with a similar control solution without Chlorhexidine for: 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. Secondary Objectives: In a nested sub-study among 12,000 births (8000 from 24,000 double blind main study and 4000 additional births) randomized to three groups: Chlorhexidine cord care (n=4000), control solution cord care (n=4000) and dry cord care (n=4000): To evaluate the sensitivity and specificity of traditionally used field definitions of omphalitis based on a combination of signs and symptom in comparison to culture results using state of art sample collection/transport, culture and bacterial identification. To evaluate reductions in bacterial colonization rates from a) umbilical cord tip, b) stump and base area in Chlorhexidine and Control Solution groups compared to currently recommended dry cord care.

Official Title
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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

Conditions
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Neonatal Mortality, Cord Care, Omphalitis

Intervention / Treatment
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* Drug: Chlorhexidine 4%
* Drug: Chlorhexidine 4%
* Other: Control cord cleaning solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 48 Hours

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHX Cord application<br>Chlorhexidine cord application for 10 days | Drug: Chlorhexidine 4%<br>* 4% liquid solution used for cord cleaning once daily for 10 days<br>Drug: Chlorhexidine 4%<br>* Chlorhexidine 4% liquid solution used for cord cleaning once daily for 10 days<br>|
| Active Comparator: Control<br>Same liquid as intervention without the chlorhexidine used for cord cleaning for 10 days once daily | Other: Control cord cleaning solution<br>* Mild soapy solution used to clean cord once daily for 10 days<br>|
| No Intervention: Dry Cord care<br>Use current recommended keep cord dry | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Mortality |  | 28 days after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Omphalitis | Using two field based definitions presence of redness or swelling with or without PUS. | Birth to 28 days of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonatal Mortality, chlorhexidine cord care, cord infections, african settings, clinical trials