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

August 24, 2023 updated by: Johns Hopkins Bloomberg School of Public Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36911

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Said M Ali, MS
  • Phone Number: +255-24-2452003
  • Email: said@phlidc.org

Study Locations

  • Tanzania
    • Zanzibar
      • Pemba, Zanzibar, Tanzania
        • PHL-IDC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 2 days (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neonatal Mortality
Time Frame: 28 days after birth
28 days after birth

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Bill and Melinda Gates Foundation
Annamalai University
Ministry of Health and Social Welfare, Zanzibar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2011

Primary Completion (Actual)

September 29, 2014

Study Completion (Actual)

September 29, 2014

Study Registration Dates

First Submitted

February 3, 2012

First Submitted That Met QC Criteria

February 7, 2012

First Posted (Estimated)

February 8, 2012

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00003027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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