NCT00719329

Brief Summary

Background: In developing countries, many babies are born at home and the umbilical cord commonly becomes infected during the first week after birth, and can be deadly. Cleansing of the cord with a low-cost antiseptic like chlorhexidine may reduce the risk of these infections. Little is known, however, about the frequency of chlorhexidine cleansing needed to impact upon the overall presence of bacteria on the stump, or regarding the changes in bacteria during the first week of life when most cord infections occur. Objectives: We will describe the profile of bacteria colonizing the umbilical cord stump of infants in rural Bangladesh and examine the role of topical chlorhexidine in altering colonization and progress of infection. We will compare the overall and bacteria-specific rate of colonization of the cord stump between infants receiving chlorhexidine cleansing of their cord through the first day or first week of life. We will also quantify the relationship between colonization of the cord stump with specific pathogens and the presence and severity of signs of umbilical cord infection (pus, redness, swelling) among these newborns. Potential Impact: More information is needed on the impact of single versus repeated applications of chlorhexidine to the cord stump, as the number of cleansing may substantially influence the feasibility of widespread scale-up in many populations. The data generated from this proposed study will guide the most appropriate design of this simple intervention and will help inform specific treatment protocols for effective management of infants with signs of umbilical cord infections.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,931

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2008

Geographic Reach
2 countries

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

April 20, 2012

Completed
Last Updated

April 20, 2012

Status Verified

March 1, 2012

Enrollment Period

1.1 years

First QC Date

July 17, 2008

Results QC Date

August 10, 2011

Last Update Submit

March 28, 2012

Conditions

Infection

Keywords

chlorhexidineumbilical cord

Outcome Measures

Primary Outcomes (3)

  • Colonization at Day 1 Swab

    Was the swab collected on the day 1 visit (usually within 24 hours of birth) positive for any organism? If so, this is defined as positive.

    First week of life

  • Colonization at Day 3 Swab

    Were any organisms found on the swab collected on at Day 03

    First Week of Life

  • Colonization at Day 7 Swab

    Were any organisms found on the swab collected on the day 07 visit?

    First Week of Life

Study Arms (3)

A

EXPERIMENTAL

Chlorhexidine cleansing of the cord for seven days

Drug: Chlorhexidine 4.0%

B

EXPERIMENTAL

Chlorhexidine cleansing of the cord for 1 day

Drug: Chlorhexidine 4.0%

C

PLACEBO COMPARATOR

Dry cord care, as recommended by WHO

Behavioral: Dry Cord Care

Interventions

Chlorhexidine 4.0%DRUG

Solution (4.0%, 7.1% CHX-D)

AB
Dry Cord CareBEHAVIORAL

Educational messages regarding clean cord care

C

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Enrolled in parent chlorhexidine cleansing trial

You may not qualify if:

  • Not enrolled in parent trial
  • First visited after 48 hours of life

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Projahnmo

Sylhet, Sylhet Division, Bangladesh

Location

Dhaka Shishu Hospital

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Infections

Limitations and Caveats

Not all possible swab data were available for each baby due to staff leave/holiday, unplanned work stoppage, child/mother absent/moved/died, swab collected but not processed - these reasons did not differ between the groups

Results Point of Contact

Title
Dr. Luke Mullany
Organization
Johns Hopkins Bloomberg School of Public Health
lmullany@jhsph.edu
410-502-2626

Study Officials

  • Luke C Mullany, PhD

    Johns Hopkins Bloomberg School of Public Health

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 21, 2008

Study Start

August 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

April 20, 2012

Results First Posted

April 20, 2012

Record last verified: 2012-03

Locations

US(1)BA(2)