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

NCT ID: NCT01729000

Last Updated: 2012-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-06-30

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.

Conditions

Neonatal Infection; Neonatal Necrotizing Enterocolitis

Keywords

prematurity; infection control; necrotizing entercolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Gloves

Intervention Type: OTHER

All staff must wear gloves for subjects that are in the experimental group.

Interventions

Gloves

All staff must wear gloves for subjects that are in the experimental group.

Intervention Type: OTHER

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

• Maximum Eligible Age: 8 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

David A Kaufman

Prinicpal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David A Kaufman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia School of Medicine

Locations

University of Virginia, Newborn Intensive Care Unit

Charlottesville, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25111196 (View on PubMed)

Other Identifiers

13971

Identifier Type: -

Identifier Source: org_study_id