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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Gloving and Handwashing to Prevent Invasive Infections in Necrotizing Enterocolitis

Conditions
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Neonatal Infection, Neonatal Necrotizing Enterocolitis

Intervention / Treatment
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* Other: Gloves


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 8 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Hand hygiene<br>All staff that have interaction with subjects will perform hand hygiene with all patient contact and before all contact with the intravenous line. | |
| Experimental: Hand hygiene plus gloving<br>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<br>* All staff must wear gloves for subjects that are in the experimental group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prematurity, infection control, necrotizing entercolitis