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

NCT03078335 | Completed

• 1 other identifier: GloveCare
• Study Type: interventional
• Target: 786
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis Newborn; Infection

Keywords

Late onset sepsis; glove based care; NICU; Non sterile gloves; infection control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time to first infection

  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 to months) throughout neonatal admissions for the 6 month duration of each study arm]

• All-cause mortality

  Duration of study (1 year)

• Proportion colonized by antibiotic resistant organisms at any point during their NICU stay

  Weeks of admission to NICU, for the duration of study (1 year)

Study Arms (2)

Glove based care

EXPERIMENTAL

The intervention is the use of non-sterile gloves, after standard hand hygiene for all routine patient care needs.

Other: Glove based care

Standard care

ACTIVE COMPARATOR

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

Interventions

Glove based care OTHER

Described in Experimental Arm: Glove based care

Glove based care

Standard of Care - Hand Hygiene OTHER

Hand Hygiene - hand washing with soap and water, or alcohol based hand rub

Standard care

Eligibility Criteria

• Age: 1 Minute+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Infants admitted to the NICU at participating sites for \> 2 days until discharge

You may not qualify if:

• Babies requiring contact precautions due to other reasons (as glove based care would be occurring)

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8N3Z5, Canada

Location

Related Publications (21)

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• Khan S, Tsang KK, Hu ZJ, Mostowiak B, El Helou S, Science M, Kaufman D, Pernica J, Thabane L, Mertz D, Loeb M. GloveCare: a pilot study in preparation for a cluster crossover randomized controlled trial of non-sterile glove-based care in preventing late-onset infection in the NICU. Pilot Feasibility Stud. 2023 Mar 23;9(1):50. doi: 10.1186/s40814-023-01271-9.

  PMID: 36959636 DERIVED

MeSH Terms

Conditions

Neonatal Sepsis; Infections

Condition Hierarchy (Ancestors)

Sepsis; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah Khan, MD, FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The final adjudication of events will be completed by two of the investigators blinded to study arm, based on a summary report of each event after completion of the pilot.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: March 13, 2017
• Study Start: June 5, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)