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

August 8, 2018 updated by: Hamilton Health Sciences Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

786

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N3Z5
        • McMaster Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Glove based care
The intervention is the use of non-sterile gloves, after standard hand hygiene for all routine patient care needs.
Other: Glove based care
Described in Experimental Arm: Glove based care
ACTIVE_COMPARATOR: Standard care
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
Hand Hygiene - hand washing with soap and water, or alcohol based hand rub

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late onset sepsis events
Time Frame: 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
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 Frame: Time from admission to NICU to discharge (days to months) throughout neonatal admissions for the 6 month duration of each study arm]
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 Frame: Time from admission to discharge (days to months) throughout neonatal admissions for the 6 month duration of each study arm]
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
Time Frame: Duration of study (1 year)
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
Time Frame: Weeks of admission to NICU, for the duration of study (1 year)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Investigators

  • Principal Investigator: Sarah Khan, MD, FRCPC, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 5, 2017

Primary Completion (ACTUAL)

June 1, 2018

Study Completion (ACTUAL)

June 1, 2018

Study Registration Dates

First Submitted

February 1, 2017

First Submitted That Met QC Criteria

March 7, 2017

First Posted (ACTUAL)

March 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GloveCare

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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