Zambia Chlorhexidine Application Trial

Phase 2

Completed

Conditions: Sepsis

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

Registration Number: NCT01241318

Lead Sponsor: Boston University

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 77535

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine cord care	Chlorhexidine gluconate (4%)	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.
Dry cord care	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Place of Delivery	28 days postpartum	The location where mothers gave birth (home versus a health facility) will be compared to their planned delivery location.
Health Facility Characteristics	12 months after study initiation	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).
Incidence of Omphalitis	28 days postpartum	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
Factors Influencing Delivery Location	28 days postpartum	Health facility characteristics and maternal decision making factors that influence choice of delivery location (health facility vs. home delivery)