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Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants

NCT00947518 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-06-25

Study results available
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Summary

The purpose of this study is to examine if single skin cleansing with 0.25% chlorhexidine affects skin condition, temperature, and bacterial colonization in stable preterm (28-36 weeks gestational age) low birth weight (1001-2000 g) infants admitted in a health facility.

Conditions

Interventions

DRUG

Chlorhexidine

Baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)

DRUG

Normal saline

Cleansing the skin (except the face)with baby wipes containing normal saline

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Mari J Sankar, MD DM · Department of Pediatrics, All India Institute of Medical Sciences, New Delhi

  • Vinod K Paul, MD PhD · Department of Pediatrics, All India Institute of Medical Sciences, New Delhi

  • Ashok K Deorari, MD MNAMS · Department of Pediatrics, All India Institute of Medical Sciences, New Delhi

  • Gary L Darmstadt, MD MS · Department of International Health, Bloomberg School of Public Health, Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
3 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2006-02-28
Completion
2006-02-28

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00947518 on ClinicalTrials.gov