NCT01241318

Zambia Chlorhexidine Application Trial

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 77,535 (actual)
• Sponsor: Boston University · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Sepsis

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2010-11-16
• Last updated: 2020-08-31
• Results posted: 2019-05-03

Locations

1 site across 1 country: Zambia