Brief Summary

A community based trial that seeks to address the effect of umbilical cord cleansing using 4.0% chlorhexidine cleansing solution

Trial Health

On Track

Trial Health Score

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

Enrollment

28,797

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started May 2007

Typical duration for phase_3

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

3.5 years study duration

First Submitted

Initial submission to the registry

February 9, 2007

Completed

4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2007

Completed

3 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed

Last Updated

October 5, 2022

Status Verified

July 1, 2007

Enrollment Period

2.5 years

First QC Date

February 9, 2007

Last Update Submit

October 3, 2022

Conditions

Omphalitis Infection

Keywords

omphalitisneonatesumbilical cordinfectioninfant mortalityneonate morbiditychlorhexidine

Outcome Measures

Primary Outcomes (2)

neonatal mortality
3 Month intervals
omphalitis among live born infants.
3 Month intervals

Secondary Outcomes (3)

newborn care practices
3 Years
care seeking behaviors
3 Years
morbidity measures, including sepsis and omphalitis
3 Years

Study Arms (3)

1

EXPERIMENTAL

4.0% chlorhexidine cleansing of the cord during home visits by project workers for the first 7 days after birth

Behavioral: CHX x 7 days

2

EXPERIMENTAL

4.0% chlorhexidine cleansing of the cord applied once by a project worker visiting the newborn in the home as soon as possible after birth

Behavioral: chx once

3

ACTIVE COMPARATOR

dry cord care

Behavioral: dry cord care

Interventions

chx onceBEHAVIORAL

4.0% chlorhexidine cleansing of the cord applied once by a project worker visiting the newborn in the home as soon as possible after birth

CHX x 7 daysBEHAVIORAL

4.0% chlorhexidine cleansing of the cord during home visits by project workers for the first 7 days after birth

dry cord careBEHAVIORAL

Household members are instructed to apply nothing to the newborn's umbilical cord stump.

Eligibility Criteria

Age1 Minute - 7 Days

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

live-born infants delivered in one of three upazillas of Sylhet District (Zakiganj, Khanaighat, Beanibazar)
married women of reproductive age within their individual target areas listed above

You may not qualify if:

individuals outside of the target area in Sylhet(Zakiganj, Khanaighat, Beanibazar)
infants not met at home by a project worker during the first seven days of life

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Johns Hopkins Bloomberg School of Public Healthlead
Government of Bangladeshcollaborator
International Centre for Diarrhoeal Disease Research, Bangladeshcollaborator
Save the Childrencollaborator
Shimantikcollaborator

Study Sites (1)

Rural Sylhet District

Sylhet, Bangladesh

Location

Related Publications (10)

Aggett PJ, Cooper LV, Ellis SH, McAinsh J. Percutaneous absorption of chlorhexidine in neonatal cord care. Arch Dis Child. 1981 Nov;56(11):878-80. doi: 10.1136/adc.56.11.878.
PMID: 7305432BACKGROUND
Baqui AH, Darmstadt GL, Williams EK, Kumar V, Kiran TU, Panwar D, Srivastava VK, Ahuja R, Black RE, Santosham M. Rates, timing and causes of neonatal deaths in rural India: implications for neonatal health programmes. Bull World Health Organ. 2006 Sep;84(9):706-13. doi: 10.2471/blt.05.026443.
PMID: 17128340BACKGROUND
Darmstadt GL, Bhutta ZA, Cousens S, Adam T, Walker N, de Bernis L; Lancet Neonatal Survival Steering Team. Evidence-based, cost-effective interventions: how many newborn babies can we save? Lancet. 2005 Mar 12-18;365(9463):977-88. doi: 10.1016/S0140-6736(05)71088-6.
PMID: 15767001BACKGROUND
Lawn JE, Cousens S, Zupan J; Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: when? Where? Why? Lancet. 2005 Mar 5-11;365(9462):891-900. doi: 10.1016/S0140-6736(05)71048-5.
PMID: 15752534BACKGROUND
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
Mullany LC, Darmstadt GL, Tielsch JM. Safety and impact of chlorhexidine antisepsis interventions for improving neonatal health in developing countries. Pediatr Infect Dis J. 2006 Aug;25(8):665-75. doi: 10.1097/01.inf.0000223489.02791.70.
PMID: 16874163BACKGROUND
Mitra DK, Mullany LC, Harrison M, Mannan I, Shah R, Begum N, Moin MI, El Arifeen S, Baqui AH; Projahnmo Study Group in Bangladesh. Incidence and risk factors of neonatal infections in a rural Bangladeshi population: a community-based prospective study. J Health Popul Nutr. 2018 Mar 9;37(1):6. doi: 10.1186/s41043-018-0136-2.
PMID: 29523194DERIVED
Mullany LC, Shah R, El Arifeen S, Mannan I, Winch PJ, Hill A, Darmstadt GL, Baqui AH. Chlorhexidine cleansing of the umbilical cord and separation time: a cluster-randomized trial. Pediatrics. 2013 Apr;131(4):708-15. doi: 10.1542/peds.2012-2951. Epub 2013 Mar 18.
PMID: 23509175DERIVED
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: 22322124DERIVED
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: 19845951DERIVED

MeSH Terms

Conditions

InfectionsInfant Death

Condition Hierarchy (Ancestors)

DeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Abdullah H Baqui, MBBS, DrPH
Johns Hopkins Bloomberg School of Public Health
PRINCIPAL INVESTIGATOR
Shams El Arifeen
International Centre for Diarrhoeal Disease Research, Bangladesh
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: FACTORIAL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 9, 2007

First Posted

February 13, 2007

Study Start

May 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2010

Last Updated

October 5, 2022

Record last verified: 2007-07

Locations

BA(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (10)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations