NCT01241318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77,535

participants targeted

Target at P75+ for phase_2 sepsis

Timeline
Completed

Started Feb 2011

Typical duration for phase_2 sepsis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

May 3, 2019

Completed
Last Updated

August 31, 2020

Status Verified

July 1, 2020

Enrollment Period

2.6 years

First QC Date

November 12, 2010

Results QC Date

December 9, 2016

Last Update Submit

August 16, 2020

Conditions

Sepsis

Keywords

neonateomphalitisneonatal mortalitymaternal healthumbilical cord infection

Outcome Measures

Primary Outcomes (2)

  • All-cause Neonatal Mortality

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

    28 days post-partum

  • 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 Outcomes (4)

  • Incidence of Omphalitis

    28 days postpartum

  • Place of Delivery

    28 days postpartum

  • Factors Influencing Delivery Location

    28 days postpartum

  • Health Facility Characteristics

    12 months after study initiation

Study Arms (2)

Chlorhexidine cord care

EXPERIMENTAL

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%)

Dry cord care

ACTIVE COMPARATOR

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

Interventions

Chlorhexidine gluconate (4%)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.

Also known as: topical antiseptic
Chlorhexidine cord care
Dry cord carePROCEDURE

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.

Dry cord care

Eligibility Criteria

Age15 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailspregnant women so only women 15 and older
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facilities throughout Southern Province

Choma, Southern Province, Zambia

Location

Related Publications (9)

  • 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.

    PMID: 19845951BACKGROUND

  • 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.

    PMID: 16546539BACKGROUND

  • 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.

    PMID: 22322124BACKGROUND

  • 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.

    PMID: 22322126BACKGROUND

  • 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.

    PMID: 35256443DERIVED

  • 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.

    PMID: 33951036DERIVED

  • 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.

    PMID: 28558800DERIVED

  • 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.

    PMID: 27693439DERIVED

  • 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.

    PMID: 25646254DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

chlorhexidine gluconateAnti-Infective Agents, Local

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Limitations and Caveats

Only 89% (37 856 of 42 570) of the target sample size was attained. When we completed a post-hoc power calculation with the obtained sample size and observed Neonatal Mortality Rate (NMR), we had 80% power to detect a 28% reduction in NMR.

Results Point of Contact

Title
Katherine Semrau (Epidemiologist, co-PI)
Organization
Ariadne Labs|BWH & HSPH
ksemrau@ariadnelabs.org
6177805311

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2010

First Posted

November 16, 2010

Study Start

February 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

August 31, 2020

Results First Posted

May 3, 2019

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)