Zambia Chlorhexidine Application Trial (ZamCAT)

• 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
  
  

• 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
  
  

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.