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

Neonatal Infection Clinical Trial

Official title:

Gloving and Handwashing to Prevent Invasive Infections in Necrotizing Enterocolitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01729000
• Other study ID #: 13971
• Status: Completed
• Phase: N/A
• First received: March 4, 2011
• Last updated: November 13, 2012
• Start date: October 2008
• Est. completion date: June 2011

Study information

• Verified date: November 2012
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 8 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Enterocolitis
• Enterocolitis, Necrotizing
• Infection
• Neonatal Infection
• Neonatal Necrotizing Enterocolitis

Intervention

Other:
• Gloves
All staff must wear gloves for subjects that are in the experimental group.

Locations

Country	Name	City	State
United States	University of Virginia, Newborn Intensive Care Unit	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive Infection	Invasive infection will be defined as growth of bacteria from culture (blood, urine, CSF, peritoneal) with clinical signs and symptoms of sepsis	Participants will be followed during their NICU hospitalization, an expected average of 3 months	No
Primary	Necrotizing enterocolitis (NEC)	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	No
Secondary	Length of stay	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	No
Secondary	Mortality	Mortality will be compared in each study arm	Participants will be followed for their entire NICU hospitalization, which is an average of 3 months	No
Secondary	Hospital cost	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	No
Secondary	Common neonatal morbidities	Common morbidities will be compared in each study arm	Participants will be followed for their entire NICU hospitalization, which is an average of 3 months	No