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

Not Applicable

Completed

• Conditions: Neonatal Infection; Neonatal Necrotizing Enterocolitis
• Interventions: Other: Gloves

• Registration Number: NCT01729000
• Lead Sponsor: University of Virginia

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 Timeline

• Study Start: 2008-10
• Study First Submitted: 2011-03-04
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-11
• Study First Submitted QC: 2012-11-13
• Last Update Submitted: 2012-11-13
• Study First Posted: 2012-11-20
• Last Update Posted: 2012-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hand hygiene plus gloving	Gloves	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.

Primary Outcome Measures

Name	Time	Method
Invasive Infection	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)	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 Outcome Measures

Name	Time	Method
Length of stay	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
Mortality	Participants will be followed for their entire NICU hospitalization, which is an average of 3 months	Mortality will be compared in each study arm
Hospital cost	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
Common neonatal morbidities	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

Trial Locations

Locations (1)

University of Virginia, Newborn Intensive Care Unit; 🇺🇸 Charlottesville, Virginia, United States