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Completed

NCT Number: NCT01729000

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

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.

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Key information

Age range

Up to 8 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia, Newborn Intensive Care Unit

Charlottesville, Virginia, 22932, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gloves

Other

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

Primary outcomes

  1. Invasive Infection

    Time frame: 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

  2. Necrotizing enterocolitis (NEC)

    Time frame: 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 outcomes

  1. Length of stay

    Time frame: 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

  2. Mortality

    Time frame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months

    Mortality will be compared in each study arm

  3. Hospital cost

    Time frame: 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

  4. Common neonatal morbidities

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

Gloving and Handwashing to Prevent Invasive Infections in Necrotizing Enterocolitis

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 20, 2012
Registry last updated
Nov 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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