Infection Clinical Trial
— GloveCareOfficial title:
Non-Sterile Glove Based Care to Prevent Late Onset Sepsis in The NICU - Cluster Crossover Randomized Controlled Pilot Study
NCT number | NCT03078335 |
Other study ID # | GloveCare |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 5, 2017 |
Est. completion date | June 1, 2018 |
Verified date | August 2018 |
Source | Hamilton Health Sciences Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 786 |
Est. completion date | June 1, 2018 |
Est. primary completion date | June 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster Children's Hospital | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Hamilton Health Sciences Corporation |
Canada,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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] | |
Secondary | 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] | |
Secondary | All-cause mortality | Number of deaths (number of patients who die during study) | Duration of study (1 year) | |
Secondary | 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) |
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