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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Johns Hopkins Bloomberg School of Public Health.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Annamalai University
PHL-Idc and Ministry of Health, Pemba, Zanzibar
Information provided by (Responsible Party):
Sunil Sazawal, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01528852
First received: February 3, 2012
Last updated: February 7, 2012
Last verified: February 2012

February 3, 2012
February 7, 2012
October 2010
December 2013   (final data collection date for primary outcome measure)
Neonatal Mortality [ Time Frame: 28 days after birth ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01528852 on ClinicalTrials.gov Archive Site
Omphalitis [ Time Frame: Birth to 28 days of life ] [ Designated as safety issue: No ]
Using two field based definitions presence of redness or swelling with or without PUS.
Same as current
Not Provided
Not Provided
 
Chlorhexidine Cordcare for Reduction in Neonatal Mortality and Omphalitis
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

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Neonatal Mortality
  • Cord Care
  • Omphalitis
  • 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
  • Other: Control cord cleaning solution
    Mild soapy solution used to clean cord once daily for 10 days
  • Experimental: CHX Cord application
    Chlorhexidine cord application for 10 days
    Interventions:
    • Drug: Chlorhexidine 4%
    • Drug: Chlorhexidine 4%
  • Active Comparator: Control
    Same liquid as intervention without the chlorhexidine used for cord cleaning for 10 days once daily
    Intervention: Other: Control cord cleaning solution
  • No Intervention: Dry Cord care
    Use current recommended keep cord dry
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
28000
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
up to 48 Hours
No
Contact: Said M Ali, MS +255-24-2452003 said@phlidc.org
Tanzania
 
NCT01528852
00003027
Yes
Sunil Sazawal, Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
  • Annamalai University
  • PHL-Idc and Ministry of Health, Pemba, Zanzibar
Not Provided
Johns Hopkins Bloomberg School of Public Health
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP