Zambia Chlorhexidine Application Trial (ZamCAT)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01241318 |
|
Recruitment Status :
Completed
First Posted : November 16, 2010
Results First Posted : May 3, 2019
Last Update Posted : August 31, 2020
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sepsis | Drug: Chlorhexidine gluconate (4%) Procedure: Dry cord care | Phase 2 Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 77535 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Impact of Chlorhexidine Cord Cleansing for Prevention of Neonatal Mortality in Zambia |
| Study Start Date : | February 2011 |
| Actual Primary Completion Date : | September 2013 |
| Actual Study Completion Date : | September 2013 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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.
|
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.
Other Name: topical antiseptic |
|
Active Comparator: 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.
|
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. |
- All-cause Neonatal Mortality [ Time Frame: 28 days post-partum ]All-cause neonatal mortality based on vital status at 28 days post-partum
- All-cause Neonatal Mortality Among Newborns Who Survived at Least First Day of Life [ Time Frame: 28 days post-partum ]All-cause mortality by day 28 of life among newborns who survive at least the first day of life
- Incidence of Omphalitis [ Time Frame: 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
- Place of Delivery [ Time Frame: 28 days postpartum ]The location where mothers gave birth (home versus a health facility) will be compared to their planned delivery location.
- Factors Influencing Delivery Location [ Time Frame: 28 days postpartum ]Health facility characteristics and maternal decision making factors that influence choice of delivery location (health facility vs. home delivery)
- Health Facility Characteristics [ Time Frame: 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | pregnant women so only women 15 and older |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241318
| Zambia | |
| Facilities throughout Southern Province | |
| Choma, Southern Province, Zambia | |
| Principal Investigator: | Davidson H Hamer, MD | Boston University Center for Global Health and Development | |
| Principal Investigator: | Katherine Semrau, PhD | Boston University Center for Global Health and Development |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boston University |
| ClinicalTrials.gov Identifier: | NCT01241318 |
| Other Study ID Numbers: |
H-29647 |
| First Posted: | November 16, 2010 Key Record Dates |
| Results First Posted: | May 3, 2019 |
| Last Update Posted: | August 31, 2020 |
| Last Verified: | July 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
|
neonate omphalitis neonatal mortality maternal health umbilical cord infection |
|
Chlorhexidine Chlorhexidine gluconate Anti-Infective Agents, Local |
Anti-Infective Agents Disinfectants Dermatologic Agents |