Chlorhexidine Cordcare for Reduction in Neonatal Mortality and Omphalitis
Condition: Neonatal Mortality; Cord Care; Omphalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      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: 
      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.
    

Intervention name(s): Chlorhexidine 4%; Chlorhexidine 4%; Control cord cleaning solution
Intervention type(s): Drug; Drug; Other
Intervention description(s): 4% liquid solution used for cord cleaning once daily for 10 days; Chlorhexidine 4% liquid solution used for cord cleaning once daily for 10 days; Mild soapy solution used to clean cord once daily for 10 days
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: neonatal Mortality; chlorhexidine cord care; cord infections; african settings; clinical trials