Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000050459
Ethics application status
Approved
Date submitted
9/08/2006
Date registered
16/01/2007
Date last updated
16/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chlorhexidine in preterm babies
Scientific title
Use of chlorhexidine as a topical antiseptic for the prevention of nosocomial sepsis in premature neonates < 29 weeks: a blinded randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nosocomial infection in preterm babies 1543 0
Condition category
Condition code
Reproductive Health and Childbirth 1642 1642 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aqueous chlorhexidine 0.5% (intervention group) applied topically. The solution is applied prior to each invasive procedure for both control and intervention groups.
Intervention code [1] 1272 0
Treatment: Other
Comparator / control treatment
Aqueous chorhexidine 0.015% (control group) applied topically. The solution is applied prior to each invasive procedure for both control and intervention groups.
Control group
Dose comparison

Outcomes
Primary outcome [1] 2265 0
Number of episodes of nosocomial infection in infants < 29 weeks
Timepoint [1] 2265 0
During stay in the neonatal intensive care unit (NICU)
Primary outcome [2] 2266 0
Skin integrity
Timepoint [2] 2266 0
Before and after application of topical antiseptic
Secondary outcome [1] 3958 0
Episodes of antibiotic use at discharge from NICU
Timepoint [1] 3958 0
Secondary outcome [2] 3959 0
Antibiotic days at discharge from NICU
Timepoint [2] 3959 0
Secondary outcome [3] 3960 0
Length of ventilation at discharge from NICU
Timepoint [3] 3960 0
Secondary outcome [4] 3961 0
Omphalitis at discharge from NICU
Timepoint [4] 3961 0
Secondary outcome [5] 3962 0
Necrotizing enterocolitis (NEC) at discharge from NICU
Timepoint [5] 3962 0
Secondary outcome [6] 3963 0
Osteomyelitis at discharge from NICU
Timepoint [6] 3963 0
Secondary outcome [7] 3964 0
Length of stay in a tertiary centre
Timepoint [7] 3964 0
Secondary outcome [8] 3965 0
Mortality before discharge from NICU
Timepoint [8] 3965 0
Secondary outcome [9] 3966 0
Developmental outcomes at 12 months corrected age
Timepoint [9] 3966 0

Eligibility
Key inclusion criteria
Inborn infants < 29 weeks. Informed parental consent.
Minimum age
0 Days
Maximum age
29 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parental consent not given. Ex utero transfer, unlikely to survive major congenital anomaly.

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)
Control / intervention solutions - the solution is pre number containers supplied by pharmacist
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of control / intervention solutions performed using the Statistical Package for Social Sciences (SPSS) solutions stratified for use in infants from two cohorts < 27 weeks & 27 - 28 weeks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Babies / families / clinicians / investigators / developmental paediatrician are blinded
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
169
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1788 0
Government body
Name [1] 1788 0
NSW Nurses Midwives Registration Board
Country [1] 1788 0
Australia
Primary sponsor type
Individual
Name
Sandie Bredemeyer
Address
Country
Secondary sponsor category [1] 1598 0
Individual
Name [1] 1598 0
Ester Carman
Address [1] 1598 0
Country [1] 1598 0
Secondary sponsor category [2] 1599 0
Individual
Name [2] 1599 0
Nick Evans
Address [2] 1599 0
Country [2] 1599 0
Secondary sponsor category [3] 1600 0
Individual
Name [3] 1600 0
Shelley Reid
Address [3] 1600 0
Country [3] 1600 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3345 0
Royal Prince Alfred Hospital - RPA Newborn Care Unit
Ethics committee address [1] 3345 0
Ethics committee country [1] 3345 0
Australia
Date submitted for ethics approval [1] 3345 0
Approval date [1] 3345 0
Ethics approval number [1] 3345 0
X04-0175

Summary
Brief summary
Strategies for reducing infection are vital in caring for the premature neonate, and include, the use of a topical antiseptic for skin cleansing prior to any invasive procedure that compromises the skin barrier. There is currently little research addressing the issue of what antiseptic solution is best and safest for use in this vulnerable neonatal population. Consequently a wide range of solutions are utilised within the NICU setting
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35717 0
Address 35717 0
Country 35717 0
Phone 35717 0
Fax 35717 0
Email 35717 0
Contact person for public queries
Name 10461 0
Sandie Bredemeyer
Address 10461 0
RPA Women and Babies
Newborn Care Unit
Missenden Rd
Camperdown NSW 2050
Country 10461 0
Australia
Phone 10461 0
+61 2 95158923 / +61 2 93510505
Fax 10461 0
+61 2 95504375
Email 10461 0
sbredemeyer@nursing.usyd.edu.au
Contact person for scientific queries
Name 1389 0
Sandie Bredemeyer
Address 1389 0
RPA Women and Babies
Newborn Care Unit
Missenden Rd Camperdown NSW 2050
Country 1389 0
Australia
Phone 1389 0
+61 2 95158923 / +61 2 93510505
Fax 1389 0
+61 2 95504375
Email 1389 0
sbredemeyer@nursing.usyd.edu.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
No additional documents have been identified.