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Trial registered on ANZCTR


Registration number
ACTRN12617000455369
Ethics application status
Approved
Date submitted
23/03/2017
Date registered
28/03/2017
Date last updated
28/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevention of Late Onset Sepsis in infants in Neonatal Intensive Care
Scientific title
Prevention of late-onset septicaemia in infants in the Neonatal Intensive Care Unit, Mater Mothers' Hospital using a bundle of strict aseptic techniques for parenteral nutrition line management
Secondary ID [1] 291521 0
Interdisciplinary Maternal Perinatal Australasian Collaborative (IMPACT) Network. Trial identification number: PT 0363
Universal Trial Number (UTN)
Trial acronym
LOS Trial
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Prematurity 302607 0
parenteral nutrition 302608 0
late-onset sepsis 302609 0
central line associated blood stream infection 302610 0
Condition category
Condition code
Infection 302132 302132 0 0
Studies of infection and infectious agents
Reproductive Health and Childbirth 302144 302144 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention technique consisted of parenteral nutrition (PN) line change management for very low birth weight infants. The PN line changes were undertaken by two experienced neonatal nurses, one having performed a surgical scrub followed by the wearing of a mask and clothing with sterile gown and gloves to prevent any breach of sterility. A full 'no touch' technique was employed.
Amino acid/dextrose solutions were changed every 48-72 hours. Solution changes were on Mondays, Wednesdays and Fridays to fit in the pharmacy requirements. Intralipid/vitamin solution which was dispensed by the pharmacy was changed every 24 hours. Continuous infusions of medications were changed every 24 hours. Clear fluid (e.g. 0.9% sodium chloride) infusions were changed every 72 hours.
PN lines were not used for other infusions, unless the infusion fluids were prepared and changed using the study intervention techniques as above.
PN lines were only used for other medications in an emergency or if no other route could reasonably be used.
3-way taps were only fitted to PN infusion lines if other infusions (e.g. sedation) were administered concurrently. Filters (in-line) - Pall Neo 96 (Pall Life Sciences, Port Washington, NY) used for PN lines. A SmartSite(Smith Medical, St Paul, MN) directly connected to all venous catheters and venous extension tubing and left in situ at line change).
PN line changes only occurred when there was tissue infiltration of fluids.
Intervention code [1] 297593 0
Prevention
Comparator / control treatment
Parenteral nutrition (PN) line changes were performed by one nurse using a no-touch sterile technique but without mask, surgical scrub, or gown and gloves.
PN lines were used as needed for other compatible infusions such as sedatives.
PN lines were used for boluses of medications including antibiotics.
Control group
Active

Outcomes
Primary outcome [1] 301565 0
The primary outcome was the occurrence of Late Onset Sepsis. Sepsis was diagnosed when there was a culture of blood or cerebrospinal fluid positive for a pathogenic bacterium or yeast together with two of the following: physical signs of infection a raised haematologic sepsis score >3 from the full blood count; a C reactive protein (CRP) >10mg/L or new onset thrombocytopaenia. Probable sepsis was defined as a positive blood culture plus only one of: a raised hematologic sepsis score in the absence of physical signs, new onset thrombocytopaenia or a raised CRP measurement, or physical signs of sepsis and normal laboratory investigations. For the purpose of analysis, episodes of probable sepsis and definite sepsis were combined. .
Timepoint [1] 301565 0
First 28 days of life
Secondary outcome [1] 333042 0
Mortality
Timepoint [1] 333042 0
To time of hospital discharge.
Secondary outcome [2] 333116 0
Chronic lung disease of prematurity diagnosed on the basis of ongoing oxygen requirements.
Timepoint [2] 333116 0
36 weeks gestation corrected for prematurity.
Secondary outcome [3] 333117 0
Retinopathy of prematurity diagnosed by indirect ophthalmoscopy by an ophthalmologist
Timepoint [3] 333117 0
Prior to hospital discharge
Secondary outcome [4] 333118 0
Duration of mechanical duration and respiratory support including nasal Continuous Positive Airways Pressure and supplemental oxygen
Timepoint [4] 333118 0
Up to the time of hospital discharge
Secondary outcome [5] 333119 0
Administration of postnatal corticosteroids for the prevention or treatment of chronic lung disease of prematurity.
Timepoint [5] 333119 0
Up to the time of hospital discharge
Secondary outcome [6] 333120 0
Duration of hospitalisation
Timepoint [6] 333120 0
At the time of hospital discharge
Secondary outcome [7] 333121 0
Developmental outcome as assessed by using the Griffiths Mental Development Scales.
Timepoint [7] 333121 0
12 months of age corrected for prematurity

Eligibility
Key inclusion criteria
Very low birth infants with a birth weight <1500 g were eligible if they survived at least 48 hours, and were considered by the clinical team to require Parenteral Nutrition.
Minimum age
2 Days
Maximum age
5 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants were excluded if they were not expected to survive to randomisation, had major congenital anomalies (including any infant expected to need neonatal surgery in the first 28 days) or had early onset sepsis (positive blood or CSF culture at < 48 hours of life).

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 was sealed in sequentially numbered opaque envelopes prepared by an administrative staff member not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence by a statistician not involved in the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
At the Mater Mothers' Hospital Neonatal Intensive Care Unit between 1998 and 1999 the incidence of Late Onset Sepsis (LOS) was 30%. A tertiary neonatal unit employing a Parenteral Nutrition management strategy similar to the study technique between 1990 and 2002 reported the incidence of LOS to range between 3.1% and 13.2% for infants <1500g. Based on an incidence of LOS of 30%, a sample size of 250 (125 per group) was calculated to demonstrate a clinically significant reduction in the incidence of LOS from 30% to 15% with Type I and II errors set at 5% and 20% respectively.
Statistical analyses: Demographic data were compared with categorical data being analyzed using Chi squared analyses or Fisher’s exact tests. Continuous data were analysed using Student’s t test if normally distributed and the Mann Whitney U test for non-parametrically distributed data. Subgroup analyses were performed for episodes of LOS in infants <1000g birth weight and for episodes of LOS that commenced whilst receiving PN. Statistical calculations were performed using Stata version 8.0.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/05/2001
Date of last participant enrolment
Anticipated
Actual
19/07/2003
Date of last data collection
Anticipated
Actual
24/11/2004
Sample size
Target
250
Accrual to date
Final
249
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 296011 0
Charities/Societies/Foundations
Name [1] 296011 0
JP Kelly Mater Research Foundation
Country [1] 296011 0
Australia
Primary sponsor type
Hospital
Name
Mater Mothers' Hospital
Address
Raymond Tce
South Brisbane
Qld 4101
Country
Australia
Secondary sponsor category [1] 294898 0
None
Name [1] 294898 0
Address [1] 294898 0
Country [1] 294898 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297272 0
Mater Health Services Research Ethics Committee
Ethics committee address [1] 297272 0
Ethics committee country [1] 297272 0
Australia
Date submitted for ethics approval [1] 297272 0
08/01/2001
Approval date [1] 297272 0
05/03/2001
Ethics approval number [1] 297272 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73538 0
A/Prof Helen Liley
Address 73538 0
Newborn Services
Mater Mothers' Hospital
Raymond Tce
South Brisbane
Qld 4101
Country 73538 0
Australia
Phone 73538 0
+61 7 3163 2733
Fax 73538 0
Email 73538 0
Helen.Liley@mater.org.au
Contact person for public queries
Name 73539 0
Helen Liley
Address 73539 0
Newborn Services
Mater Mothers' Hospital
Raymond Tce
South Brisbane
Qld 4101
Country 73539 0
Australia
Phone 73539 0
+61 7 3163 2733
Fax 73539 0
Email 73539 0
Helen.Liley@mater.org.au
Contact person for scientific queries
Name 73540 0
Helen Liley
Address 73540 0
Newborn Services
Mater Mothers' Hospital
Raymond Tce
South Brisbane
Qld 4101
Country 73540 0
Australia
Phone 73540 0
+61 7 3163 2733
Fax 73540 0
Email 73540 0
Helen.Liley@mater.org.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbasePrevention of neonatal late-onset sepsis: A randomised controlled trial.2017https://dx.doi.org/10.1186/s12887-017-0855-3
N.B. These documents automatically identified may not have been verified by the study sponsor.