NCT01723501

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

3 active sites

Status
withdrawn

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

Study Start

First participant enrolled

November 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2012

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

First QC Date

November 6, 2012

Last Update Submit

July 15, 2016

Conditions

Neonatal SepsisNeonatal Mortality Rate

Keywords

chlorhexidinesepsisneonatalwhole-body skin cleansing

Outcome Measures

Primary Outcomes (1)

  • Sepsis within first 7 days of life

    Sepsis would be defined on the basis of clinical course, lab parameters including culture results and antibiotic treatment given.

    First 7 days of life

Secondary Outcomes (5)

  • Readmissions & mortality rates within neonatal period

    28 days

  • Body temperature at 0, 5, 15, 30 minutes after application

    30 minutes

  • Skin condition

    24 ±6 hours

  • Skin colonization rates

    24 ±6 hours

  • Chlorhexidine percutaneous absorption

    48 ±6 hours

Study Arms (2)

sterile water

PLACEBO COMPARATOR

sterile water wipes

Drug: sterile water

0.25% chlorhexidine

EXPERIMENTAL

0.44% chlorhexidine digluconate wipes which will release 0.25% free chlorhexidine

Drug: 0.25% chlorhexidine

Interventions

0.25% chlorhexidineDRUG

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

Also known as: Chx
0.25% chlorhexidine
sterile waterDRUG

Sterile water wipes (placebo)

sterile water

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Birth weight less than 1500 g

You may not qualify if:

  • Birth weight \<750 g
  • Major congenital malformations
  • Total duration of positive pressure ventilation (PPV) \> 3 mins OR chest compressions
  • Shock- requiring inotropes \>10 mic/kg/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Maulana Azad Medical College

New Delhi, National Capital Territory of Delhi, 110002, India

Location

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Vardhman Medical College and Safdarjung Hospital

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Related Links

MeSH Terms

Conditions

Neonatal SepsisSepsis

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

InfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Vinod K Paul, MD, PhD

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Head, Department of Pediatrics

Study Record Dates

First Submitted

November 6, 2012

First Posted

November 8, 2012

Study Start

November 1, 2012

Last Updated

July 18, 2016

Record last verified: 2016-07

Locations

IN(3)