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

November 13, 2012 updated by: David A Kaufman, University of Virginia

Gloving and Handwashing to Prevent Invasive Infections in Necrotizing Enterocolitis

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

All infants who had a birth weight of less than or equal to 1000 grams or who were born less than 29 weeks gestation were eligible for this study. 120 subjects were randomized by day of life(dol) 8 to one of two study groups--hand hygiene or hand hygiene plus gloving. Study signs were placed at the bedside and on the isolette sides of each infant with the appropriate study group guidelines.

The investigators goal was to target the time period these infants are at high-risk for infection or NEC and its associated mortality. The targeted time was the first 4 weeks of life or longer while intravenous access is still required. The average age for the first episode of late-onset sepsis is 22(+/-0.5) days (median: 17 days; 75th percentile: 28 days; 95th percentile: 57 days). The majority of infections that occur after 4 weeks of life are in patients still requiring IV access (peripheral or central). The presence of an intravenous line in this group of preterm infants correlates with the presence of risk factors for infection that would necessitate the need for intravenous access including: parenteral nutrition, lipid infusion, use of broad spectrum antibiotics, and the intravenous line itself (if it is a central venous catheter). This strategy focused on the individual infant's risks, limits exposure to and decreases cost of intervention.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Virginia
      • Charlottesville, Virginia, United States, 22932
        • University of Virginia, Newborn Intensive Care Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • greater than 7 days of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Hand hygiene
All staff that have interaction with subjects will perform hand hygiene with all patient contact and before all contact with the intravenous line.
Experimental: Hand hygiene plus gloving
All staff that have interaction with subjects will perform hand hygiene and wear gloves with all patient contact and before all contact with the intravenous line.
All staff must wear gloves for subjects that are in the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive Infection
Time Frame: Participants will be followed during their NICU hospitalization, an expected average of 3 months
Invasive infection will be defined as growth of bacteria from culture (blood, urine, CSF, peritoneal) with clinical signs and symptoms of sepsis
Participants will be followed during their NICU hospitalization, an expected average of 3 months
Necrotizing enterocolitis (NEC)
Time Frame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
NEC will be defined as stage II or greater using Bell's modified criteria
Participants will be followed for their entire NICU hospitalization, which is an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
Length of stay will be compared in each study arm
Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
Mortality
Time Frame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
Mortality will be compared in each study arm
Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
Hospital cost
Time Frame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
Hospital costs will be compared in each study arm
Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
Common neonatal morbidities
Time Frame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
Common morbidities will be compared in each study arm
Participants will be followed for their entire NICU hospitalization, which is an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: David A Kaufman, MD, University of Virginia School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

March 4, 2011

First Submitted That Met QC Criteria

November 13, 2012

First Posted (Estimate)

November 20, 2012

Study Record Updates

Last Update Posted (Estimate)

November 20, 2012

Last Update Submitted That Met QC Criteria

November 13, 2012

Last Verified

November 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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