Clinical trial NCT03078335: Glove-based Care in the NICU to Prevent Late Onset Sepsis
Official title: Non-Sterile Glove Based Care to Prevent Late Onset Sepsis in The NICU - Cluster Crossover Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis Newborn
Infection
Keywords: Late onset sepsis
glove based care
NICU
Non sterile gloves
infection control
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 786
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Late onset sepsis events
timeFrame: 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 outcomes:
measure: Time to first infection
timeFrame: Time from admission to NICU to discharge (days to months) throughout neonatal admissions for the 6 month duration of each study arm]
measure: Length of stay
timeFrame: Time from admission to discharge (days to months) throughout neonatal admissions for the 6 month duration of each study arm]
measure: All-cause mortality
timeFrame: Duration of study (1 year)
measure: Proportion colonized by antibiotic resistant organisms at any point during their NICU stay
timeFrame: Weeks of admission to NICU, for the duration of study (1 year)
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Sarah Khan, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
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