Neonatal Infection, Neonatal Necrotizing Enterocolitis
Conditions
Keywords
prematurity, infection control, necrotizing entercolitis
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.
Interventions
OTHERGloves
All staff must wear gloves for subjects that are in the experimental group.
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 8 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed