Zambia Chlorhexidine Application Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sepsis

Intervention / Treatment
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* Drug: Chlorhexidine gluconate (4%)
* Procedure: Dry cord care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine cord care<br>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. | Drug: Chlorhexidine gluconate (4%)<br>* 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.<br>* Other names: topical antiseptic;|
| Active Comparator: Dry cord care<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Neonatal Mortality | All-cause neonatal mortality based on vital status at 28 days post-partum | 28 days post-partum | 
| All-cause Neonatal Mortality Among Newborns Who Survived at Least First Day of Life | All-cause mortality by day 28 of life among newborns who survive at least the first day of life | 28 days post-partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Omphalitis | 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 | 28 days postpartum | 
| Place of Delivery | The location where mothers gave birth (home versus a health facility) will be compared to their planned delivery location. | 28 days postpartum | 
| Factors Influencing Delivery Location | Health facility characteristics and maternal decision making factors that influence choice of delivery location (health facility vs. home delivery) | 28 days postpartum | 
| Health Facility Characteristics | Characterization of the health services available to pregnant women, postpartum women and their offspring as assessed by comprehensive health facility and health worker surveys. This data was assessed and reported on 100 facilities (10 district hospitals and 90 health facilities). | 12 months after study initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonate, omphalitis, neonatal mortality, maternal health, umbilical cord infection