- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01729000
Study to Determine if Gloving in Addition to Hand Hygiene Will Prevent Invasive Infections and Necrotizing Enterocolitis
Gloving and Handwashing to Prevent Invasive Infections in Necrotizing Enterocolitis
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Virginia
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Charlottesville, Virginia, United States, 22932
- University of Virginia, Newborn Intensive Care Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
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All staff must wear gloves for subjects that are in the experimental group.
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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
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Participants will be followed during their NICU hospitalization, an expected average of 3 months
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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
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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
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Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David A Kaufman, MD, University of Virginia School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13971
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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