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Trial registered on ANZCTR


Registration number
ACTRN12621001717842
Ethics application status
Approved
Date submitted
15/11/2021
Date registered
16/12/2021
Date last updated
16/12/2021
Date data sharing statement initially provided
16/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of medical glue on bleeding after intravenous line insertion in babies: a clinical trial.
Scientific title
The effect of cyanoacrylate glue on bleeding after peripherally inserted central catheter insertion in neonates: a randomised controlled trial.
Secondary ID [1] 304916 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bleeding after percutaneously inserted central catheter (PICC) insertion in neonates 324313 0
Central line dislodgment in neonates 324314 0
Central line associated infection in neonates 324315 0
Condition category
Condition code
Reproductive Health and Childbirth 321801 321801 0 0
Complications of newborn
Anaesthesiology 322006 322006 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Routine PICC line insertion (sterile technique, chlorhexidine skin preparation, insertion of 24G/28G PICC via introducer needle/cannula, confirmation of correct placement with contrast-enhanced x-ray) and standard adhesive dressings applied (Steristrips and Tegaderm). Addition of 0.15mL of cyanoacrylate glue applied to the insertion point via SecurePortIV applicator device. Intervention performed by a neonatal clinician once only, taking approximately 30 minutes.
Intervention code [1] 322199 0
Treatment: Devices
Comparator / control treatment
Routine PICC line insertion (sterile technique, chlorhexidine skin preparation, insertion of 24G/28G PICC via introducer needle/cannula, confirmation of correct placement with contrast-enhanced x-ray), standard adhesive dressings applied (Steristrips and Tegaderm). Intervention performed by a neonatal clinician once only, taking approximately 30 minutes.
Control group
Active

Outcomes
Primary outcome [1] 329565 0
Post-insertion bleeding after PICC insertion. This will be directly observed at 24 hours after line insertion by the baby’s bedside nurse. Any evidence of bleeding will be recorded as positive post-insertion bleeding. This will be recorded on a specific trial assessment form which will be filed in the baby’s medical chart.
Timepoint [1] 329565 0
24 hours post PICC insertion.
Secondary outcome [1] 403006 0
PICC line dislodgement. This will be assessed by review of the baby’s medical records.
Timepoint [1] 403006 0
This will be monitored on a weekly basis for all babies included in the study for the duration their PICC line remains in situ.
Secondary outcome [2] 403007 0
Central line associated infection. This will be assessed by the diagnosis of line infection being made by the baby’s treating medical team, on the basis of positive blood culture results.
Timepoint [2] 403007 0
This will be monitored on a weekly basis for all babies included in the study for the duration their PICC line remains in situ.

Eligibility
Key inclusion criteria
Any neonates requiring PICC line insertion will be considered. There is no specific age requirement, any baby admitted to the neonatal intensive care nursery can be considered.
Minimum age
No limit
Maximum age
3 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neonates with a history of adverse skin reactions with dressings/adhesives would be excluded, as well as in those whose parent/s are unable to give informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Our study will use allocation envelopes when babies are recruited into the trial. These are generated per the below field. Each envelope will be labeled with a participant number (eg A001) and contain two cards — an allocation card (control/treatment) and a data collection card. The envelopes will be opaque to prevent unblinding and sealed. The envelopes will be made available within the unit for medical officers (MOs) or neonatal nurse practitioners (NNPs) who are inserting lines. After obtaining consent, the MO/NNP would open an envelope to determine which group the neonate would be allocated to. The allocation card would be placed back into the envelope and re-sealed and kept in the neonate’s chart. The data collection card would be left in the baby’s chart for subsequent use. All envelopes and cards would have to be accounted for at the end of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Mater Research will generate a simple randomisation schedule for our study with participant identification numbers for each baby and an allocation to either the treatment or control group. Simple randomisation will be undertaken using a randomisation table created by computer software (i.e. computerised sequence generation). This randomisation schedule will be provided to a research assistant not directly involved with the study, as well as detailed instructions on how to generate labels, cards and envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We have sought statistical advice for our outcomes analysis from Alison Griffin, a biostatistician in the Statistics Unit at the QIMR Berghofer Medical Research Institute. Incidence rates for our study’s primary and secondary outcomes will be determined for each study arm. For our primary outcome of post-insertion bleeding, any difference between the two arms will be evaluated by calculation of 95% confidence intervals and p-values. p <0.05 will be considered statistically significant. For each of our secondary outcomes, we will report absolute risk reduction and/or relative risk reduction with 95% confidence intervals.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
92
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21101 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 35957 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 309295 0
Hospital
Name [1] 309295 0
Mater Mothers’ Hospital
Country [1] 309295 0
Australia
Primary sponsor type
Other
Name
Mater Health
Address
Mater Mothers’ Hospital
Raymond Terrace
South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 310265 0
None
Name [1] 310265 0
Address [1] 310265 0
Country [1] 310265 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309126 0
Mater Misericordiae Ltd HREC
Ethics committee address [1] 309126 0
Ethics committee country [1] 309126 0
Australia
Date submitted for ethics approval [1] 309126 0
Approval date [1] 309126 0
22/09/2021
Ethics approval number [1] 309126 0

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

Contacts
Principal investigator
Name 113070 0
Dr Anand Ramineni
Address 113070 0
Mater Mothers’ Hospital
Raymond Terrace
South Brisbane QLD 4101
Country 113070 0
Australia
Phone 113070 0
+61 413207747
Fax 113070 0
Email 113070 0
a.ramineni@icloud.com
Contact person for public queries
Name 113071 0
Anand Ramineni
Address 113071 0
Mater Mothers’ Hospital
Raymond Terrace
South Brisbane QLD 4101
Country 113071 0
Australia
Phone 113071 0
+61 413207747
Fax 113071 0
Email 113071 0
a.ramineni@icloud.com
Contact person for scientific queries
Name 113072 0
Anand Ramineni
Address 113072 0
Mater Mothers’ Hospital
Raymond Terrace
South Brisbane QLD 4101
Country 113072 0
Australia
Phone 113072 0
+61 413207747
Fax 113072 0
Email 113072 0
a.ramineni@icloud.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14093Study protocol    382503-(Uploaded-01-12-2021-15-55-00)-Study-related document.pdf
14094Ethical approval    382503-(Uploaded-15-11-2021-13-51-18)-Study-related document.pdf



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.