Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000758101
Ethics application status
Approved
Date submitted
4/05/2019
Date registered
22/05/2019
Date last updated
22/05/2019
Date data sharing statement initially provided
22/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Spinal cord Position in Neonates At Lumbar puncture (SPINAL)
Scientific title
Interobserver variability of clinician performed ultrasound to assess the spinal cord termination in neonates
Secondary ID [1] 296666 0
None
Universal Trial Number (UTN)
U1111-1232-8017
Trial acronym
SPINE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Termination of spinal cord 312700 0
Condition category
Condition code
Neurological 311201 311201 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will be infants admitted to the hospital who require lumbar puncture. There are no exclusions.
The spinal cord will be examined by ultrasound using linear array probe in mid sagittal (up and down the body) and transverse planes (across the body) and location of the termination of the spinal cord defined in relation to surrounding vertebral bodies.
Ultrasound examinations will be performed by 2 practitioners, Neonatal Consultants or Senior Neonatal Trainees who are experienced in the use of ultrasound. They will have training in the method for examination of the spine and will be allowed to familiarise themselves with this technique.
The procedure will be performed twice by the first observer and twice by a second observer who is blinded to the results of the first. Each observation should take approximately 5 minutes to complete and will occur on the same day.
Intervention code [1] 314374 0
Treatment: Devices
Intervention code [2] 314523 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319961 0
Interobserver variability of clinician performed ultrasound to determine the end of the spinal cord.
Timepoint [1] 319961 0
Study completion
Secondary outcome [1] 369992 0
Infant tolerance of procedure (number of events of cardioresp instability documented on continuous monitoring)
Timepoint [1] 369992 0
At the time of ultrasound
Secondary outcome [2] 370404 0
perception of infant comfort qualitatively rated by primary nurse/midwife using a scale rating infant comfort 1-3 (1=uncomfortable, 2=neutral, 3=comfortable)
Timepoint [2] 370404 0
at the time of ultrasound

Eligibility
Key inclusion criteria
The participants will be infants admitted to the hospital who require lumbar puncture.
Minimum age
0 Days
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no exclusions.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary outcome: Interobserver variability of clinician performed ultrasound to determine the end of the spinal cord.
This will be reported as a mean, standard deviation of the difference.
For the continuous variables of spinal cord level, intraclass correlation (ICC) will be calculated as a measure of reliability. ICC is interpreted as <0.40=poor, 0.40 to 0.75=fair to good and >0.75=excellent reliability. Bland-Altman plots with 95% limits of agreement (LOA) are calculated as a measure of absolute agreement.
Secondary outcomes: Infant tolerance of procedure) and perception of infant comfort rated by primary nurse/midwife.
This will be reported qualitatively.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2019
Actual
Date of last participant enrolment
Anticipated
1/01/2020
Actual
Date of last data collection
Anticipated
1/01/2020
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 13686 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 26376 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 301245 0
Hospital
Name [1] 301245 0
Women's and Children's Hospital
Country [1] 301245 0
Australia
Primary sponsor type
Individual
Name
Lydia Kennedy
Address
Women's and Children's Hospital
Department of Neonatal Medicine
72 King William Street
North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 300880 0
Hospital
Name [1] 300880 0
Women's and Children's Hospital
Address [1] 300880 0
72 King William Street
North Adelaide SA 5006
Country [1] 300880 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301984 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 301984 0
Research Secreteriate
Level 2 Samuel Way Building
72 King William Road
North Adelaide SA 5006
Ethics committee country [1] 301984 0
Australia
Date submitted for ethics approval [1] 301984 0
20/11/2018
Approval date [1] 301984 0
05/02/2019
Ethics approval number [1] 301984 0
HREC/18/WCHN/163

Summary
Brief summary
Aim:
To determine the interobserver variability of ultrasound of the spinal cord performed on infants by clinicians.
Hypothesis:
We hypothesise that clinician performed ultrasound reliably and reproducibly identifies the end of the spinal cord in newborn infants.
If reliable, the use of spinal ultrasound would enhance the safety of infants undergoing lumbar puncture by ensuring that the location of puncture occurs below the end of the spinal cord thus eliminating the risk of cord injury.
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 88762 0
Dr Lydia Kennedy
Address 88762 0
Department of Neonatology
Women's and Children's Hospital
72 King William Street
North Adelaide SA 5006
Country 88762 0
Australia
Phone 88762 0
+61 8 81617000
Fax 88762 0
Email 88762 0
[email protected]
Contact person for public queries
Name 88763 0
Dr Lydia Kennedy
Address 88763 0
Department of Neonatology
Women's and Children's Hospital
72 King William Street
North Adelaide SA 5006
Country 88763 0
Australia
Phone 88763 0
+61 8 81617000
Fax 88763 0
Email 88763 0
[email protected]
Contact person for scientific queries
Name 88764 0
Dr Lydia Kennedy
Address 88764 0
Department of Neonatology
Women's and Children's Hospital
72 King William Street
North Adelaide SA 5006
Country 88764 0
Australia
Phone 88764 0
+61 8 81617000
Fax 88764 0
Email 88764 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not approved by ethics committee


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1993Ethical approval    376426-(Uploaded-04-05-2019-15-06-48)-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.