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Zambia Chlorhexidine Application Trial (ZamCAT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Boston University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Ministry of Health, Zambia
Zambia Center for Applied Health Research and Development
Information provided by (Responsible Party):
Davidson Hamer, Boston University
ClinicalTrials.gov Identifier:
NCT01241318
First received: November 12, 2010
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Sepsis
Drug: Chlorhexidine gluconate (4%)
Procedure: Dry cord care
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of Chlorhexidine Cord Cleansing for Prevention of Neonatal Mortality in Zambia

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • All-cause neonatal mortality [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    All-cause neonatal mortality based on vital status at 28 days post-partum

  • All-cause neonatal mortality among newborns who survived at least first day of life [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    All-cause mortality by day 28 of life among newborns who survive at least the first day of life


Secondary Outcome Measures:
  • Incidence of omphalitis [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

    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

  • Place of delivery [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    The location where mothers gave birth (home versus a health facility) will be compared to their planned delivery location.

  • Factors influencing delivery location [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    Health facility characteristics and maternal decision making factors that influence choice of delivery location (health facility vs. home delivery)

  • Health facility characteristics [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    Characterization of the health services available to pregnant women, postpartum women and their offspring as assessed by comprehensive health facility and health worker surveys


Estimated Enrollment: 85140
Study Start Date: January 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chlorhexidine cord care
Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.
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.
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241318

Contacts
Contact: Davidson H Hamer, MD 617 414 1260 dhamer@bu.edu
Contact: Katherine Semrau, PhD 617 414 1276 ksemrau@bu.edu

Locations
Zambia
Facilities throughout Southern Province Recruiting
Choma, Southern Province, Zambia
Sponsors and Collaborators
Boston University
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
  More Information

Additional Information:
Publications:
Responsible Party: Davidson Hamer, Professor of International Health and Medicine, Boston University
ClinicalTrials.gov Identifier: NCT01241318     History of Changes
Other Study ID Numbers: ZamCAT
Study First Received: November 12, 2010
Last Updated: September 5, 2012
Health Authority: United States: Institutional Review Board
Zambia: Ministry of Health
Zambia: Pharmaceutical Regulatory Authority
Zambia: Research Ethics Committee

Keywords provided by Boston University:
neonate
omphalitis
neonatal mortality
maternal health
umbilical cord infection

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014