Zambia Chlorhexidine Application Trial (ZamCAT)

August 16, 2020 updated by: Boston University

Impact of Chlorhexidine Cord Cleansing for Prevention of Neonatal Mortality in Zambia

This will be a cluster-randomized controlled trial to assess whether washing the umbilical cord with a disinfectant (4% chlorhexidine) helps to reduce neonatal deaths in Zambia when compared to the current standard of care, dry cord care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary goals of the Zambia Chlorhexidine Application Trial (ZamCAT) are to assess whether daily 4% chlorhexidine cord cleansing is more effective than dry cord care for the prevention of neonatal deaths and omphalitis (umbilical cord infection) in Southern Province, Zambia. Secondary goals are to 1) compare where pregnant women plan to deliver and where they actually deliver, and 2) to describe the health services network available to pregnant and postpartum women in case of serious illness among the women and their newborn infants.

Clusters consisting of individual health centers and their respective catchment areas will be assigned to one of two arms. In the intervention clusters, mothers will apply 4% chlorhexidine to their infants daily until 3 days after the cord completely separates. Mothers in the control clusters will use dry cord care as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.

In order to achieve the 4th Millennium Development Goal of reducing child mortality by two-thirds, simple, inexpensive, and scalable interventions are required. If the use of a 4% chlorhexidine umbilical cord wash effectively reduces neonatal mortality, this will be a low-cost intervention that can be easily translated from a research project into a program for countrywide implementation in Zambia. These results will also add to the limited evidence base about the effectiveness of interventions for reduction of neonatal mortality in sub-Saharan Africa.

Study Type

Interventional

Enrollment (Actual)

77535

Phase

  • Phase 2
  • 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 Locations

  • Zambia
    • Southern Province
      • Choma, Southern Province, Zambia
        • Facilities throughout Southern Province

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

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pregnant women in the 2nd or 3rd trimester
  • Age 15 years and above
  • Pregnant women who plan to stay in the study area (catchment area of the health facility) for delivery and one month post partum
  • Willingness to provide cord care as per the protocol of their cluster
  • Willingness to provide informed consent

Exclusion Criteria:

  • Pregnant women who are not willing to provide cord care as per the protocol of their cluster
  • Pregnant women who are not willing to provide informed consent
  • Pregnant women in the 1st trimester
  • Pregnant women under age 15 years

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Chlorhexidine cord care
Mothers located in health facility catchment areas assigned to this arm will apply Chlorhexidine gluconate (4%) to their infants daily until three days after the cord completely separates. Bottles of chlorhexidine is provided to women during antenatal care.
Drug: Chlorhexidine gluconate (4%)
Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.
Other Names:
  • topical antiseptic
ACTIVE_COMPARATOR: Dry cord care
Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.
Procedure: Dry cord care
Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause Neonatal Mortality
Time Frame: 28 days post-partum
All-cause neonatal mortality based on vital status at 28 days post-partum
28 days post-partum
All-cause Neonatal Mortality Among Newborns Who Survived at Least First Day of Life
Time Frame: 28 days post-partum
All-cause mortality by day 28 of life among newborns who survive at least the first day of life
28 days post-partum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Omphalitis
Time Frame: 28 days postpartum

Omphalitis, or umbilical cord infection, defined as:

  • presence of umbilical cord pus and mild, moderate or severe redness
  • moderate or severe redness without the presence of umbilical cord pus
28 days postpartum
Place of Delivery
Time Frame: 28 days postpartum
The location where mothers gave birth (home versus a health facility) will be compared to their planned delivery location.
28 days postpartum
Factors Influencing Delivery Location
Time Frame: 28 days postpartum
Health facility characteristics and maternal decision making factors that influence choice of delivery location (health facility vs. home delivery)
28 days postpartum
Health Facility Characteristics
Time Frame: 12 months after study initiation
Characterization of the health services available to pregnant women, postpartum women and their offspring as assessed by comprehensive health facility and health worker surveys. This data was assessed and reported on 100 facilities (10 district hospitals and 90 health facilities).
12 months after study initiation

Collaborators and Investigators

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

Sponsor

Boston University

Collaborators

Bill and Melinda Gates Foundation
Ministry of Health, Zambia
Zambia Center for Applied Health Research and Development

Investigators

  • Principal Investigator: Davidson H Hamer, MD, Boston University Center for Global Health and Development
  • Principal Investigator: Katherine Semrau, PhD, Boston University Center for Global Health and Development

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

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

February 1, 2011

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

November 12, 2010

First Submitted That Met QC Criteria

November 12, 2010

First Posted (ESTIMATE)

November 16, 2010

Study Record Updates

Last Update Posted (ACTUAL)

August 31, 2020

Last Update Submitted That Met QC Criteria

August 16, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-29647

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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