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Clinical Trials/NCT01729000
NCT01729000CompletedNot Applicable

Gloving and Handwashing to Prevent Invasive Infections in Necrotizing Enterocolitis

University of Virginia2 sites in 1 country124 target enrollmentStarted: October 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
124
Locations
2
Primary Endpoint
Invasive Infection

Study Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
— to 8 Days (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Length of stay(Participants will be followed for their entire NICU hospitalization, which is an average of 3 months)
  • Mortality(Participants will be followed for their entire NICU hospitalization, which is an average of 3 months)
  • Hospital cost(Participants will be followed for their entire NICU hospitalization, which is an average of 3 months)
  • Common neonatal morbidities(Participants will be followed for their entire NICU hospitalization, which is an average of 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

David A Kaufman

Prinicpal Investigator

University of Virginia

Study Sites (2)

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