Glove-based Care in the NICU to Prevent Late Onset Sepsis

Study Overview
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Brief Summary
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Babies that get an infection after 3 days of age while in the Neonatal Intensive Care Unit is not related to their delivery but to the hospital environment. Preventing these infections results in shorter hospital stays for babies, less risk of long term health problems and less health care resources required to care for them. Hand washing alone doesn't remove all bacteria from the hands of healthcare workers, and studies have shown that infections in adults and children admitted to hospital decrease if health care providers use clean, non- sterile gloves when treating patients. The main focus of this study will be to find out if using gloves when caring for newborns in the NICU is better than washing hands alone. McMaster Children's Hospital and The Hospital for Sick Children will be the pilot sites to participate in a future larger study where some infants will be cared for using non-sterile gloves, and others will be cared for using the standard hand washing method.

Detailed Description
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Late onset sepsis (LOS) is defined as infection occurring after 72 hours of life in neonates admitted to the Neonatal Intensive Care Unit (NICU). LOS can lead to severe complications including death, major neurologic sequelae, and contribute to increased length of stay and costs of care. These hospital acquired infections are largely preventable. Hand washing prior to any patient care is considered the cornerstone of prevention and is the standard of care in the NICU. Adherence to hand washing however is difficult to achieve, with estimates of compliance among health care workers ranging from 30% to 60%. Observational studies in at-risk critically ill children suggest a reduction in hospital acquired infections and central line associated bloodstream infections with glove based care in addition to hand hygiene. One small single-centre randomized trial of glove based care versus hand hygiene alone to assess LOS rates in extremely premature infants in the NICU showed a reduction in gram positive infections and central line infections with glove-based care. We propose to test the effect of glove based care in an adequately powered, rigorously designed and conducted, cluster randomized controlled trial (RCT) after completing a feasibility pilot study. This pilot study will include all babies in the NICU being randomized to 6 months of glove based care or standard of care, and then the following 6 months will be the opposite arm. All health care provider contact with the infant will require gloves in the intervention arm, but families of infants admitted to the NICU will not be required to wear gloves. The main outcome measured will be the number of episodes of infections in the blood, urinary tract, and cerebrospinal fluid comparing the glove intervention arm against the control arm. Invasive infections are an important challenge for infants admitted to the NICU and reducing this risk can improve the quality and quantity of neonatal survivors from the NICU.

Official Title
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Non-Sterile Glove Based Care to Prevent Late Onset Sepsis in The NICU - Cluster Crossover Randomized Controlled Pilot Study

Conditions
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Sepsis Newborn, Infection

Intervention / Treatment
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* Other: Glove based care
* Other: Standard of Care - Hand Hygiene


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants admitted to the NICU at participating sites for > 2 days until discharge Exclusion Criteria: Babies requiring contact precautions due to other reasons (as glove based care would be occurring)

Ages Eligible for Study
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Minimum Age: 1 Minute

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This pilot study is a single centre NICU based cluster-randomized crossover trial, with 2 crossover periods each lasting 6 months, and a 2-week washout period in between.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glove based care<br>The intervention is the use of non-sterile gloves, after standard hand hygiene for all routine patient care needs. | Other: Glove based care<br>* Described in Experimental Arm: Glove based care<br>|
| Active Comparator: Standard care<br>The control group will provide standard care, that is, hand hygiene before all patient, bed, and intravenous catheter contact. | Other: Standard of Care - Hand Hygiene<br>* Hand Hygiene - hand washing with soap and water, or alcohol based hand rub<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late onset sepsis events | The anticipated incidence of LOS is 10% of patients based on Canadian Neonatal Network retrospective data. Infection is defined as blood stream, urinary tract, or cerebrospinal fluid infection based on 1 or more positive cultures with a bacterial or fungal pathogen (2 cultures required for Coagulase negative staphylococcus), at least 2 compatible signs and symptoms (including temperature instability, hemodynamic changes, respiratory distress and increased inflammatory markers), and the need for antimicrobial treatment. | Weeks of admission to the NICU. Infection must occur at >72 hours of age, throughout neonatal admissions for the 6 month duration of each study arm | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first infection | Time from admission to NICU to first infection in days | Time from admission to NICU to discharge (days to months) throughout neonatal admissions for the 6 month duration of each study arm] | 
| Length of stay | Time from admission to discharge (days) | Time from admission to discharge (days to months) throughout neonatal admissions for the 6 month duration of each study arm] | 
| All-cause mortality | Number of deaths (number of patients who die during study) | Duration of study (1 year) | 
| Proportion colonized by antibiotic resistant organisms at any point during their NICU stay | Proportion of infants who become colonized with antibiotic resistant organisms during surveillance screening as part of routine care (number of patients) | Weeks of admission to NICU, for the duration of study (1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Late onset sepsis, glove based care, NICU, Non sterile gloves, infection control