Zambia Chlorhexidine Application Trial (ZamCAT)
|Sepsis||Drug: Chlorhexidine gluconate (4%) Procedure: Dry cord care||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Impact of Chlorhexidine Cord Cleansing for Prevention of Neonatal Mortality in Zambia|
- All-cause neonatal mortality [ Time Frame: 2.5 years ]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 ]All-cause mortality by day 28 of life among newborns who survive at least the first day of life
- Incidence of omphalitis [ Time Frame: 2.5 years ]
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 ]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 ]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 ]Characterization of the health services available to pregnant women, postpartum women and their offspring as assessed by comprehensive health facility and health worker surveys
|Study Start Date:||February 2011|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241318
|Facilities throughout Southern Province|
|Choma, Southern Province, Zambia|
|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|