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Completed

NCT Number: NCT01241318

Zambia Chlorhexidine Application Trial

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Facilities throughout Southern Province

Choma, Southern Province, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine gluconate (4%)

Drug

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

Dry cord care

Procedure

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ZamCAT

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 16, 2010
Registry last updated
Aug 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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