Zambia Chlorhexidine Application Trial (ZamCAT)

Boston University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Sepsis

Treatments: Drug: Chlorhexidine gluconate (4%); Procedure: Dry cord care

Study type: Interventional

Funder types: Other

Identifiers

NCT01241318

H-29647

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77,535 patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women in the 2nd or 3rd trimester
• Age 15 years and above
• Pregnant women who plan to stay in the study area (catchment area of the health facility) for delivery and one month post partum
• Willingness to provide cord care as per the protocol of their cluster
• Willingness to provide informed consent

Exclusion criteria

• Pregnant women who are not willing to provide cord care as per the protocol of their cluster
• Pregnant women who are not willing to provide informed consent
• Pregnant women in the 1st trimester
• Pregnant women under age 15 years

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77,535 participants in 2 patient groups

Chlorhexidine cord care

Experimental group

Description:

Mothers located in health facility catchment areas assigned to this arm will apply Chlorhexidine gluconate (4%) to their infants daily until three days after the cord completely separates. Bottles of chlorhexidine is provided to women during antenatal care.

Treatment:

Drug: Chlorhexidine gluconate (4%)

Dry cord care

Active Comparator group

Description:

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.

Treatment:

Procedure: Dry cord care