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

NCT01729000 | Completed

• 1 other identifier: 13971
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Infection; Neonatal Necrotizing Enterocolitis

Keywords

prematurity; infection control; necrotizing entercolitis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (4)

• 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

Study Arms (2)

Hand hygiene

NO INTERVENTION

All staff that have interaction with subjects will perform hand hygiene with all patient contact and before all contact with the intravenous line.

Hand hygiene plus gloving

EXPERIMENTAL

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.

Other: Gloves

Interventions

Gloves OTHER

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

Hand hygiene plus gloving

Eligibility Criteria

• Age: Up to 8 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight \<1000 grams or gestational age ≤28 weeks
• less than or equal to 7 days of age

You may not qualify if:

• greater than 7 days of age

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia, Newborn Intensive Care Unit

Charlottesville, Virginia, 22932, United States

Location

Related Publications (1)

• 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.

  PMID: 25111196 DERIVED

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Premature Birth

Interventions

Gloves, Protective

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Protective Clothing; Personal Protective Equipment; Protective Devices; Equipment and Supplies; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• David A Kaufman, MD

  University of Virginia School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Study Record Dates

• First Submitted: March 4, 2011
• First Posted: November 20, 2012
• Study Start: October 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 20, 2012

Record last verified: 2012-11

Locations

US (1)