Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000618156
Ethics application status
Approved
Date submitted
10/04/2019
Date registered
26/04/2019
Date last updated
26/04/2019
Date data sharing statement initially provided
26/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Gloves On study: Effect of non-sterile gloves in addition to hand hygiene on late-onset sepsis in preterm infants
Scientific title
The Gloves On study: Effect of non-sterile gloves in addition to hand hygiene on late-onset sepsis in preterm infants
Secondary ID [1] 297814 0
Nil known
Universal Trial Number (UTN)
U1111-1230-7217
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Late-onset sepsis 312177 0
Prematurity 312181 0
Condition category
Condition code
Infection 310729 310729 0 0
Studies of infection and infectious agents
Reproductive Health and Childbirth 310731 310731 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
'Gloves On'
Sepsis continues to be a significant problem for preterm infants, and late-onset sepsis (LOS; sepsis with signs developing after 48 hours of life) contributes to the majority of infections. Hand contamination is the most common source of infection in neonatal LOS. Even after appropriate hand hygiene, microbes may remain present on the skin, but the use of clean non-sterile gloves may further reduce microbial contamination. Observational and small randomised controlled trial data that non-sterile glove use in addition to hand hygiene prior to patient contact reduces late-onset sepsis rates in preterm infants and sick children.

The intervention in the 'Gloves On' study is the use of non-sterile glove use in addition to hand hygiene prior to direct patient contact for all infants <29 weeks gestation. These encounters will include any non-sterile procedures including handling of infants (feeding and bathing), insertion or handling of peripheral intravenous cannulas, handling of central lines, and any time the cot/humidicrib is accessed. All patients included in the study will have signs indicating their study inclusion placed at the end of the cot/crib. During the intervention period of non-sterile glove use, alcohol rub as well as non-sterile gloves will be made available at every bed space to remind staff. Prior to every patient contact, hand hygiene and donning of non-sterile gloves will occur by staff members.
Other indications for sterile glove use and hand hygiene are unchanged and as per individual unit policy.
Non-sterile glove use is for health care professionals only.
The intervention period is for the first 28 days of life, or while the infant has intravenous access in situ.
Glove use and hand hygiene compliance will be monitored through each unit's hand hygiene auditors, who already collect this data for the National Hand Hygiene Audit.
Intervention code [1] 314058 0
Prevention
Intervention code [2] 314263 0
Behaviour
Comparator / control treatment
The comparator is the standard practice in that Neonatal Unit. Standard practice is hand hygiene prior to any patient contact, with the addition of non-sterile gloves for any procedure likely to involve contact with blood or other body fluid, non-intact skin or mucous membranes.
Control group
Active

Outcomes
Primary outcome [1] 319577 0
Late-onset sepsis defined as per the Australia and New Zealand Neonatal Network Data Set definition;

The presence of blood or cerebrospinal fluid (CSF) infection with initial symptoms occurring from 48 hours after birth, where the following conditions apply:

o Isolation of an organism from at least one blood or CSF culture or identification via polymerase chain reaction in CSF
o After consideration of clinical and laboratory evidence, a decision is made to give the patient antibiotics or antifungals with therapeutic intent against this organism
Timepoint [1] 319577 0
At discharge home for the first time
Secondary outcome [1] 368768 0
All-cause mortality
Timepoint [1] 368768 0
At discharge home for the first time
Secondary outcome [2] 368769 0
Infection-related mortality
Timepoint [2] 368769 0
At discharge home for the first time
Secondary outcome [3] 368770 0
Length of hospital stay in days, taken from NICUS database. NICUS is the electronic neonatal data platform. Data is entered by clinical staff and audited by trained research nurses. It is in use in every level 5 NICU in NSW and ACT.
Timepoint [3] 368770 0
At discharge home for the first time
Secondary outcome [4] 368771 0
Clinical sepsis defined as:

Symptoms and signs consistent with infection occurring after 48 hours AND
Treated by clinicians as infection AND
Laboratory evidence consistent with infection
Timepoint [4] 368771 0
At discharge home for the first time
Secondary outcome [5] 368773 0
Type of antibiotic from NICUS database
Timepoint [5] 368773 0
At discharge home for the first time
Secondary outcome [6] 368774 0
Duration of ventilation in hours taken from NICUS database
Timepoint [6] 368774 0
At discharge home for the first time
Secondary outcome [7] 368775 0
Proven necrotising enterocolitis (NEC) as per the ANZNN definition:
1. At least one systemic sign: temperature instability, apnoea, bradycardia or lethary AND one intestinal sign: a residual of more than 25% of the previous feed on 2 consecutive occasions, abdominal distension, vomiting or faecal blood
2. Has a profile consistent with definite NEC including at least one of the following: abdominal wall cellulitis and palpable abdominal mass, or pneumatosis intestinalis, or portal vein gas, or a persistent dilated loop on serial X-rays. or a surgical or post-mortem diagnosis.
3. Plus the baby warranted treatment for NEC, which included nil by mouth and antibiotics.
Timepoint [7] 368775 0
At discharge home for the first time
Secondary outcome [8] 368776 0
Respiratory support at 36 weeks post menstrual age from NICUS database
Timepoint [8] 368776 0
36 weeks post menstrual age
Secondary outcome [9] 368777 0
Retinopathy of prematurity: worst stage of retinopathy in either eye prior to going home on examination by a paediatric opthalmologist
Timepoint [9] 368777 0
At discharge home for the first time
Secondary outcome [10] 368796 0
Central line-associated blood stream infection defined as late-onset sepsis above AND the culture date is within 48 hours of a central line being in situ and there is no other source of infection.
Timepoint [10] 368796 0
At discharge home for the first time
Secondary outcome [11] 368797 0
Time to establish full feeds in days from NICUS database
Timepoint [11] 368797 0
At discharge home for the first time
Secondary outcome [12] 368798 0
Duration of umbilical venous access in hours from NICUS database
Timepoint [12] 368798 0
At discharge home for the first time
Secondary outcome [13] 369662 0
Duration of antibiotic in hours, from NICUs database
Timepoint [13] 369662 0
At discharge home for the first time
Secondary outcome [14] 369663 0
Duration of CPAP in hours taken from NICUS database
Timepoint [14] 369663 0
At discharge home for the first time
Secondary outcome [15] 369664 0
Duration of nasal hi-flow device in hours taken from NICUS database
Timepoint [15] 369664 0
At discharge home for the first time
Secondary outcome [16] 369665 0
Duration of oxygen in hours taken from NICUS database
Timepoint [16] 369665 0
At discharge home for the first time
Secondary outcome [17] 369666 0
Duration of peripherally inserted central line access in hours from NICUS database
Timepoint [17] 369666 0
At discharge home for the first time
Secondary outcome [18] 369667 0
Number of central venous lines (umbilical or peripherally inserted) from NICUS database
Timepoint [18] 369667 0
At discharge home for the first time

Eligibility
Key inclusion criteria
All infants born at <29 weeks completed gestational age at a participating NICU .
Minimum age
No limit
Maximum age
3 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusions at a trial level.
Parents may withdraw their infant from NICUs data collection if they wish.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of clusters to the timing of the intervention will be generated by a computer generated random number table by the biostatistician who will not be involved in clinical aspects of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Clusters will be assigned to the timing of the intervention (control and interventions periods) using a computer generated random number table by the biostatistician who will not be involved in the clinical aspects of the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a stepped-wedge cluster randomised controlled trial. The cluster is each participating Neonatal Intensive Care Unit. The trial implements non-sterile glove use as routine practice in the participating unit in a stepped wedge fashion. All infants born at less than 29 weeks and in a participating unit will be included. There will be no exclusions at trial level. Ethics approval is in place for an individual waiver of consent to confirm with the cluster design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size is based on an absolute reduction in sepsis of 12% (from 25% to 13%) with alpha of 0.05 and intra-cluster coefficient of 0.01 and 9 time periods (8 clusters plus baseline) of 10 weeks. This gives a total sample size of 864 infants with an average cluster size of 65 per year, consistent with each unit’s admission rates for infants less than or equal to 28 weeks gestation per year. NICUS and ANZNN data shows an average sepsis rate of 25% for infants born at less than or equal to 28 weeks gestation. Recruitment would be completed in 20 months with real time infection data available a month after completion. Characteristics of the infants and clusters, by intervention exposure, will be summarised using frequencies and percentages, means and standard deviations, or medians and interquartile ranges as appropriate. The primary analyses will follow the intention to treat principle, with infants analysed according to whether their birth took place during the control or intervention periods, irrespective of whether the intervention had been implemented as planned. To test the effect of the intervention, adjusting for the systematically different observation periods during the control and intervention steps and for clustering in the data, we will use a linear mixed model for continuous (and normally distributed) outcomes or an appropriate generalised linear mixed model for non-normally distributed outcomes. All mixed models will include a random effect for cluster and fixed effects for intervention and study time period. The effect of the intervention on binary outcomes will be reported as absolute and relative risk differences with 95%CI, and on continuous outcomes will be reported as adjusted mean differences with 95%CI, for the intervention period versus the control.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2019
Actual
Date of last participant enrolment
Anticipated
18/01/2021
Actual
Date of last data collection
Anticipated
31/03/2021
Actual
Sample size
Target
864
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 13500 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 13501 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 13502 0
John Hunter Hospital - New Lambton
Recruitment hospital [4] 13503 0
Westmead Hospital - Westmead
Recruitment hospital [5] 13504 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 13505 0
Nepean Hospital - Kingswood
Recruitment hospital [7] 13506 0
Royal Hospital for Women - Randwick
Recruitment hospital [8] 13507 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 26125 0
2031 - Randwick
Recruitment postcode(s) [2] 26119 0
2050 - Camperdown
Recruitment postcode(s) [3] 26120 0
2065 - St Leonards
Recruitment postcode(s) [4] 26122 0
2145 - Westmead
Recruitment postcode(s) [5] 26123 0
2170 - Liverpool
Recruitment postcode(s) [6] 26121 0
2305 - New Lambton
Recruitment postcode(s) [7] 26126 0
2605 - Garran
Recruitment postcode(s) [8] 26124 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 302338 0
Self funded/Unfunded
Name [1] 302338 0
Country [1] 302338 0
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 302218 0
None
Name [1] 302218 0
Address [1] 302218 0
Country [1] 302218 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303013 0
Sydney Local Health District Ethics Review Committee
Ethics committee address [1] 303013 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
Camperdown
NSW 2050
Ethics committee country [1] 303013 0
Australia
Date submitted for ethics approval [1] 303013 0
02/06/2017
Approval date [1] 303013 0
29/06/2017
Ethics approval number [1] 303013 0
X15-0282 and HREC/15/RPAH/384

Summary
Brief summary
Infection in preterm babies (babies born early) remains a common problem in neonatal units – up to 1 in 4 babies born at less than 29 weeks of pregnancy develops a serious infection at some time during their stay. Preterm babies are vulnerable to infection, and the impact of infection can be far-reaching: not only can infection make babies critically unwell, but can also contribute to poorer health and development when babies grow up into childhood. It is crucial that neonatal units try to reduce infection rates.

One of the main sources of infection comes from bugs that are usually carried on babies’ or healthcare workers’ skin. These bugs are carried harmlessly on the skin, but if they get into the bloodstream they can cause infection. The ‘Gloves On’ study is looking at a simple intervention to try to prevent infection: using gloves when staff touch babies in addition to the handwashing that we would normally do before we touch any baby. Gloves are not used routinely at present. We think using gloves would reduce infection by lowering the rate of transmission of bugs from healthcare workers’ hands to babies and back again. We would like to assess the impact of using gloves on infection rates in preterm babies, as well as making sure it is safe for babies, and safe and acceptable to the families and everyone who uses them.

This simple and cheap intervention would be easy to introduce into every neonatal unit if it is shown to be successful and cost-effective. This would mean reduced numbers of infections in fragile preterm babies, with improved survival rates. Lower infection rates means shorter times in hospital for the babies and reduced costs for hospitals. Lower infection rates would also improve health and development of these babies when they grow into young children, making life better for families around Australia.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92162 0
Dr Rowena McMullan
Address 92162 0
Department of Newborn Care
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 92162 0
Australia
Phone 92162 0
+61 2 9515 8248
Fax 92162 0
+61 2 95504375
Email 92162 0
rowena.mcmullan@health.nsw.gov.au
Contact person for public queries
Name 92163 0
Dr Rowena McMullan
Address 92163 0
Department of Newborn Care
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 92163 0
Australia
Phone 92163 0
+61 2 9515 8248
Fax 92163 0
+61 2 95504375
Email 92163 0
rowena.mcmullan@health.nsw.gov.au
Contact person for scientific queries
Name 92164 0
Dr Rowena McMullan
Address 92164 0
Department of Newborn Care
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 92164 0
Australia
Phone 92164 0
+61 2 9515 8248
Fax 92164 0
+61 2 95504375
Email 92164 0
rowena.mcmullan@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified IPD collected during the trial.
When will data be available (start and end dates)?
Immediately following publication, no determined end date at present.
Available to whom?
Case-by-case basis at the discretion of the primary sponsor.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to approvals by the principal investigator on rowena.mcmullan@health.nsw.gov.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.