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Chlorhexidine Cordcare for Reduction in Neonatal Mortality and Omphalitis (CHX-Pemba)

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ClinicalTrials.gov Identifier: NCT01528852
Recruitment Status : Unknown
Verified February 2012 by Sunil Sazawal, Johns Hopkins Bloomberg School of Public Health.
Recruitment status was:  Recruiting
First Posted : February 8, 2012
Last Update Posted : February 8, 2012
Sponsor:
Collaborators:
Annamalai University
Ministry of Health and Social Welfare, Zanzibar
Information provided by (Responsible Party):
Sunil Sazawal, Johns Hopkins Bloomberg School of Public Health

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Neonatal Mortality Cord Care Omphalitis Drug: Chlorhexidine 4% Other: Control cord cleaning solution Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Study Start Date : October 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CHX Cord application
Chlorhexidine cord application for 10 days
 Drug: Chlorhexidine 4%
4% liquid solution used for cord cleaning once daily for 10 days

Drug: Chlorhexidine 4%
Chlorhexidine 4% liquid solution used for cord cleaning once daily for 10 days
Active Comparator: Control
Same liquid as intervention without the chlorhexidine used for cord cleaning for 10 days once daily
 Other: Control cord cleaning solution
Mild soapy solution used to clean cord once daily for 10 days
No Intervention: Dry Cord care
Use current recommended keep cord dry


Outcome Measures
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Primary Outcome Measures :
  1. Neonatal Mortality [ Time Frame: 28 days after birth ]

Secondary Outcome Measures :
  1. Omphalitis [ Time Frame: Birth to 28 days of life ]
    Using two field based definitions presence of redness or swelling with or without PUS.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Hour to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528852


Contacts
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Contact: Said M Ali, MS +255-24-2452003 said@phlidc.org

Locations
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Tanzania
PHL-IDC Recruiting
Pemba, Zanzibar, Tanzania
Principal Investigator: Said M Ali, MS         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Annamalai University
Ministry of Health and Social Welfare, Zanzibar
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sunil Sazawal, Associate Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01528852    
Other Study ID Numbers: 00003027
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: February 2012
Keywords provided by Sunil Sazawal, Johns Hopkins Bloomberg School of Public Health:
neonatal Mortality
chlorhexidine cord care
cord infections
african settings
clinical trials
Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
 Anti-Infective Agents
Disinfectants
Dermatologic Agents