Sepsis Clinical Trial
Official title:
Impact of Chlorhexidine Cord Cleansing for Prevention of Neonatal Mortality in Zambia
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.
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