Zambia Chlorhexidine Application Trial

Sepsis Clinical Trial

— ZamCAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241318
• Other study ID #: H-29647
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2011
• Est. completion date: September 2013

Study information

• Verified date: July 2020
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 77535
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis

Intervention

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.

Locations

Country	Name	City	State
Zambia	Facilities throughout Southern Province	Choma	Southern Province

Sponsors (4)

Lead Sponsor	Collaborator
Boston University	Bill and Melinda Gates Foundation, Ministry of Health, Zambia, Zambia Center for Applied Health Research and Development

Country where clinical trial is conducted

Zambia, 

References & Publications (4)

Arifeen SE, Mullany LC, Shah R, Mannan I, Rahman SM, Talukder MR, Begum N, Al-Kabir A, Darmstadt GL, Santosham M, Black RE, Baqui AH. The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial. Lancet. 2012 Mar 17;379(9820):1022-8. doi: 10.1016/S0140-6736(11)61848-5. Epub 2012 Feb 8. — View Citation

Mullany LC, Darmstadt GL, Khatry SK, Katz J, LeClerq SC, Shrestha S, Adhikari R, Tielsch JM. Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomised trial. Lancet. 2006 Mar 18;367(9514):910-8. — View Citation

Mullany LC, El Arifeen S, Winch PJ, Shah R, Mannan I, Rahman SM, Rahman MR, Darmstadt GL, Ahmed S, Santosham M, Black RE, Baqui AH. Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial. BMC Pediatr. 2009 Oct 21;9:67. doi: 10.1186/1471-2431-9-67. — View Citation

Soofi S, Cousens S, Imdad A, Bhutto N, Ali N, Bhutta ZA. Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial. Lancet. 2012 Mar 17;379(9820):1029-36. doi: 10.1016/S0140-6736(11)61877-1. Epub 2012 Feb 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Neonatal Mortality	All-cause neonatal mortality based on vital status at 28 days post-partum	28 days post-partum
Primary	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	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
Secondary	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
Secondary	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
Secondary	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