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Chlorhexidine Skin Application for Prevention of Infection in Infants Weighing <1500 g at Birth

NCT01723501 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2016-07-18

No results posted yet for this study

Summary

Purpose of this study is determine if skin application of chlorhexidine at birth would reduce infection in infants weighing \<1500 g at birth.

Conditions

  • Neonatal Sepsis
  • Neonatal Mortality Rate

Interventions

DRUG

0.25% chlorhexidine

0.44% chlorhexidine di-gluconate body wipes which would release 0.25% free chlorhexidine on application

DRUG

sterile water

Sterile water wipes (placebo)

Sponsors & Collaborators

  • Maulana Azad Medical College

    collaborator OTHER

  • Vardhman Mahavir Medical College And Safdarjung Hospital

    collaborator OTHER

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Vinod K Paul, MD, PhD · All India Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30

Countries

  • India

Study Locations

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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 NCT01723501 on ClinicalTrials.gov