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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
77,535
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.
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.
Facilities throughout Southern Province
Choma, Southern Province, Zambia
All-cause Neonatal Mortality
All-cause neonatal mortality based on vital status at 28 days post-partum
Time frame: 28 days post-partum
All-cause Neonatal Mortality Among Newborns Who Survived at Least First Day of Life
All-cause mortality by day 28 of life among newborns who survive at least the first day of life
Time frame: 28 days post-partum
Incidence of Omphalitis
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
Time frame: 28 days postpartum
Place of Delivery
The location where mothers gave birth (home versus a health facility) will be compared to their planned delivery location.
Time frame: 28 days postpartum
Factors Influencing Delivery Location
Health facility characteristics and maternal decision making factors that influence choice of delivery location (health facility vs. home delivery)
Time frame: 28 days postpartum
Health Facility Characteristics
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).
Time frame: 12 months after study initiation
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