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

Completed · Not applicable

Conditions studied: Neonatal Infection, Neonatal Necrotizing Enterocolitis

In brief

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.

Key facts

Study ID

NCT01729000

Run by

University of Virginia

People needed

124

Starts

2008-10-01

Expected to finish

2011-06-01

Last updated by the study team

2012-11-20

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Birth weight <1000 grams or gestational age ≤28 weeks
• less than or equal to 7 days of age

You may not qualify if…

• greater than 7 days of age

Where it is running

• University of Virginia, Newborn Intensive Care Unit — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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