Clinical trial NCT01729000: Study to Determine if Gloving in Addition to Hand Hygiene Will Prevent Invasive Infections and Necrotizing Enterocolitis
Official title: Gloving and Handwashing to Prevent Invasive Infections in Necrotizing Enterocolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Infection
Neonatal Necrotizing Enterocolitis
Keywords: prematurity
infection control
necrotizing entercolitis
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2012-11-20
Enrollment: 124
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Invasive Infection
timeFrame: Participants will be followed during their NICU hospitalization, an expected average of 3 months
measure: Necrotizing enterocolitis (NEC)
timeFrame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
Secondary outcomes:
measure: Length of stay
timeFrame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
measure: Mortality
timeFrame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
measure: Hospital cost
timeFrame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
measure: Common neonatal morbidities
timeFrame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia, Newborn Intensive Care Unit
state: Virginia
Study officials:
affiliation: University of Virginia School of Medicine
name: David A Kaufman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaufman DA, Blackman A, Conaway MR, Sinkin RA. Nonsterile glove use in addition to hand hygiene to prevent late-onset infection in preterm infants: randomized clinical trial. JAMA Pediatr. 2014 Oct;168(10):909-16. doi: 10.1001/jamapediatrics.2014.953.