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SepsisPhase 2/3ZamCATNCT01241318

Zambia Chlorhexidine Application Trial

A Phase 2/3 study testing Chlorhexidine gluconate (4%) and Dry cord care in people with Sepsis, run by Boston University at 1 site in Zambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for
Sepsis
What is being tested?
Chlorhexidine gluconate (4%) and Dry cord care
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77,535 participants
Where
1 siteZambia
Study dates
Feb 2011to Sep 2013
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Zambia1 site

  • Facilities throughout Southern Province

    Choma, Southern Province

Other trials in Zambia

About this study

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

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.

Read the 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.

Conditions
Sepsis
Being tested
Chlorhexidine gluconate (4%), Dry cord care
Keywords
neonate, omphalitis, neonatal mortality, maternal health, umbilical cord infection
Medical subject headings
Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chlorhexidine gluconate (4%)Drug

    Also called topical antiseptic

    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 careProcedure or surgery

    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.

Study groups in NCT01241318
Study groupRoleWhat they receive
Chlorhexidine cord careExperimentalMothers 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.
Receives: Drug: Chlorhexidine gluconate (4%)
Dry cord careActive comparatorMothers 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.
Receives: Procedure: Dry cord care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause Neonatal Mortality

    All-cause neonatal mortality based on vital status at 28 days post-partum

    Measured: 28 days post-partum

  2. 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

    Measured: 28 days post-partum

Secondary outcomes (4)

  1. 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

    Measured: 28 days postpartum

  2. Place of Delivery

    The location where mothers gave birth (home versus a health facility) will be compared to their planned delivery location.

    Measured: 28 days postpartum

  3. Factors Influencing Delivery Location

    Health facility characteristics and maternal decision making factors that influence choice of delivery location (health facility vs. home delivery)

    Measured: 28 days postpartum

  4. 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).

    Measured: 12 months after study initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2010 (estimated)
  2. Study startFeb 2011
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
77,535 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01241318
Sponsor's protocol ID
H-29647
Acronym
ZamCAT
Status last verified
Jul 2020
First submitted
12 Nov 2010
Last updated
31 Aug 2020
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 19845951

  • 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. doi: 10.1016/S0140-6736(06)68381-5.

    PubMed 16546539

  • 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.

    PubMed 22322124

  • 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.

    PubMed 22322126

  • Solomon H, Henry EG, Herlihy J, Yeboah-Antwi K, Biemba G, Musokotwane K, Bhutta A, Hamer DH, Semrau KEA. Intended versus actual delivery location and factors associated with change in delivery location among pregnant women in Southern Province, Zambia: a prespecified secondary observational analysis of the ZamCAT. BMJ Open. 2022 Mar 7;12(3):e055288. doi: 10.1136/bmjopen-2021-055288.

    PubMed 35256443

  • Park JH, Hamer DH, Mbewe R, Scott NA, Herlihy JM, Yeboah-Antwi K, Semrau KEA. Components of clean delivery kits and newborn mortality in the Zambia Chlorhexidine Application Trial (ZamCAT): An observational study. PLoS Med. 2021 May 5;18(5):e1003610. doi: 10.1371/journal.pmed.1003610. eCollection 2021 May.

    PubMed 33951036

  • Henry EG, Semrau K, Hamer DH, Vian T, Nambao M, Mataka K, Scott NA. The influence of quality maternity waiting homes on utilization of facilities for delivery in rural Zambia. Reprod Health. 2017 May 30;14(1):68. doi: 10.1186/s12978-017-0328-z.

    PubMed 28558800

  • Semrau KEA, Herlihy J, Grogan C, Musokotwane K, Yeboah-Antwi K, Mbewe R, Banda B, Mpamba C, Hamomba F, Pilingana P, Zulu A, Chanda-Kapata P, Biemba G, Thea DM, MacLeod WB, Simon JL, Hamer DH. Effectiveness of 4% chlorhexidine umbilical cord care on neonatal mortality in Southern Province, Zambia (ZamCAT): a cluster-randomised controlled trial. Lancet Glob Health. 2016 Nov;4(11):e827-e836. doi: 10.1016/S2214-109X(16)30215-7. Epub 2016 Sep 29.

    PubMed 27693439

  • Hamer DH, Herlihy JM, Musokotwane K, Banda B, Mpamba C, Mwangelwa B, Pilingana P, Thea DM, Simon JL, Yeboah-Antwi K, Grogan C, Semrau KE. Engagement of the community, traditional leaders, and public health system in the design and implementation of a large community-based, cluster-randomized trial of umbilical cord care in Zambia. Am J Trop Med Hyg. 2015 Mar;92(3):666-72. doi: 10.4269/ajtmh.14-0218. Epub 2015 Feb 2.

    PubMed 25646254

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Chlorhexidine gluconate (4%) and Dry cord care in people with Sepsis, run by Boston University at 1 site in Zambia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Neonatal Mortality (time frame: 28 days post-partum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01241318, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.

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