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Study to Determine if Gloving in Addition to Hand Hygiene Will Prevent Invasive Infections and Necrotizing Enterocolitis

NCT01729000 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2012-11-20

No results posted yet for this study

Summary

The purpose of this study is to compare the additional use of gloves (with handwashing before and after gloving) for all patient contact while infants have intravenous (central or peripheral) access in a RCT. Preterm infants \<1000 grams or less than 29 weeks gestational age will be randomized after birth to either a handwashing-gloving group or handwashing only group. The primary outcome will be the incidence of invasive infections (bacterial or fungal) or necrotizing enterocolitis. Secondary outcomes will include hospital days, preterm morbidities, mortality, and hospital costs.

Conditions

  • Neonatal Infection
  • Neonatal Necrotizing Enterocolitis

Interventions

OTHER

Gloves

All staff must wear gloves for subjects that are in the experimental group.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • David A Kaufman, MD · University of Virginia School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
8 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

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 NCT01729000 on ClinicalTrials.gov