NCT00198679

Brief Summary

Given the potential of skin cleansing with chlorhexidine as a safe, feasible, and cost-effective intervention for reducing neonatal death in developing country settings, this study follows a trial already underway in Nepal to test the impact of a single cleansing of the skin with baby wipes cotaining chlorahexidine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_4

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

Study Start

First participant enrolled

March 1, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

April 20, 2018

Status Verified

May 1, 2006

Enrollment Period

1 year

First QC Date

September 12, 2005

Last Update Submit

April 18, 2018

Conditions

Skin Diseases, Infectious

Keywords

skin cleansingBangladeshSkin FloraNewborninfectious diseasechlorhexidine

Outcome Measures

Primary Outcomes (1)

  • Wiping of newborn skin will be done immediatly upon enrollment in study, with follow up during hosptial stay and up to two weeks to determine skin condition and presence of any kind of skin infection.

Interventions

ChlorhexidineDRUG

Eligibility Criteria

AgeUp to 48 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infant admitted to Special Care Nursery at Dhaka Shishu Hospital less than 48 hours chronological age
  • parental consent must be obtained

You may not qualify if:

  • infants being admitted for major surgical procedure which is attended by high rate of infectious complications
  • sepsis
  • clinically-evident skin infection
  • generalized skin disease
  • structural defect of the skin involving greater than 5% of the body surface
  • with a major congenital anomaly
  • with a known immunodeficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dhaka Shishu Hospital

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Skin Diseases, InfectiousCommunicable Diseases

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

InfectionsSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Gary Darmstadt, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

March 1, 2004

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

April 20, 2018

Record last verified: 2006-05

Locations

BA(1)