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Zambia Chlorhexidine Application Trial (ZamCAT)

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ClinicalTrials.gov Identifier: NCT01241318
Recruitment Status : Completed
First Posted : November 16, 2010
Results First Posted : May 3, 2019
Last Update Posted : August 31, 2020
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Ministry of Health, Zambia
Zambia Center for Applied Health Research and Development
Information provided by (Responsible Party):
Boston University

Brief Summary:
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 or disease Intervention/treatment Phase
Sepsis Drug: Chlorhexidine gluconate (4%) Procedure: Dry cord care Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77535 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Chlorhexidine Cord Cleansing for Prevention of Neonatal Mortality in Zambia
Study Start Date : February 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013


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 Name: 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.




Primary Outcome Measures :
  1. All-cause Neonatal Mortality [ Time Frame: 28 days post-partum ]
    All-cause neonatal mortality based on vital status at 28 days post-partum

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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)

  4. 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).



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women so only women 15 and older
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

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): NCT01241318


Locations
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Zambia
Facilities throughout Southern Province
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
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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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01241318    
Other Study ID Numbers: H-29647
First Posted: November 16, 2010    Key Record Dates
Results First Posted: May 3, 2019
Last Update Posted: August 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Boston University:
neonate
omphalitis
neonatal mortality
maternal health
umbilical cord infection
Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents