NCT00271440

Brief Summary

The purpose of this study is to compare the reductions in skin flora of newborns after a single cleansing of the body with three concentrations of chlorhexidine (0.25%, 0.5%, 1.0%) and to examine the safety of skin cleansing in neonates in Nepal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
286

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_1

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2005

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

April 5, 2010

Status Verified

April 1, 2010

Enrollment Period

3 months

First QC Date

December 29, 2005

Last Update Submit

April 2, 2010

Conditions

Bacterial Infection

Keywords

chlorhexidineneonatalskin floraskin cleansingbacterial colonization

Outcome Measures

Primary Outcomes (1)

  • Skin flora reduction across treatment groups

    prior to wipe, 2hrs after, and 24hrs after

Secondary Outcomes (1)

  • Serum concentrations of chlorhexidine 24 hours after wipe

    24 hrs after wipe

Study Arms (3)

CHX 1.0%

EXPERIMENTAL

1.0% CHX wiping

Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)

CHX 0.5%

EXPERIMENTAL

0.5% Chlorhexidine

Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)

CHX 0.25%

EXPERIMENTAL

chlorhexidine cleansing with pre-soaked pre-sealed wipe

Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)

Interventions

skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)PROCEDURE
CHX 0.25%CHX 0.5%CHX 1.0%

Eligibility Criteria

AgeUp to 3 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • babies born at Tribhuvan University Teaching Hospital
  • greater than 1500 grams

You may not qualify if:

  • less than 1500 grams
  • requires major surgical procedure
  • clinically evident skin infection
  • generalized skin disease
  • major congenital anomoly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tribhuvan University Teaching Hospital

Kathmandu, Nepal

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Luke C Mullany, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 29, 2005

First Posted

January 2, 2006

Study Start

January 1, 2006

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

April 5, 2010

Record last verified: 2010-04

Locations

NE(1)