Zambia Chlorhexidine Application Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

77535 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-09-30

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.

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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.

Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Chlorhexidine cord care

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.

Group Type EXPERIMENTAL

Chlorhexidine gluconate (4%)

Intervention Type DRUG

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.

Dry cord care

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.

Group Type ACTIVE_COMPARATOR

Dry cord care

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Other Intervention Names

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topical antiseptic

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

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes