Determining the success rate of performing LP with ultrasound in children under 24 months
Design
A concealed, randomized, sham controlled clinical trial with a parallel group design of 80 patients, enrolled in 2023
Settings and conduct
This clinical trial study will be performed on neonates under 24 months that needs LP referred to Taleghani Hospital in Gorgan in 2023.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Children aged 24 months and younger who needed to undergo a diagnostic or treatment procedure for LP
Exclusion criteria:
Known spinal abnormalities such as spina bifida and
Mentally retarded parents of the patient
No identification documents
Absolute and relative contraindications of LP include: Skin infection at the site of skin puncture to perform LP, evidence of increased intracranial pressure, any space-occupying lesion in the cranial cavity, trauma, lumbar mass, change in mental capacity, focal nerve deficit, papillary edema, immunocompromised patients, recent seizure or any bleeding disease or coagulation defect
Intervention groups
The intervention group includes patients who, undergone portable ultrasound, mark the puncture site for lumbar puncture, and then perform lumbar puncture.
Main outcome variables
Success in doing LP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221208056751N1
Registration date:2022-12-17, 1401/09/26
Registration timing:prospective
Last update:2022-12-17, 1401/09/26
Update count:0
Registration date
2022-12-17, 1401/09/26
Registrant information
Name
Parisa Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 911 177 7042
Email address
atamann1393@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-10, 1401/10/20
Expected recruitment end date
2023-03-06, 1401/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of ultrasound-guided LP success rate in children under 24 months ; Randomized clinical trial with control group
Public title
Evaluation of ultrasound-guided LP success rate in children under 24 months
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 24 months and younger who needed to undergo a diagnostic or treatment procedure for LP
Exclusion criteria:
Known spinal abnormalities such as spina bifida and...
Mentally retarded parents of the patient
No identification documents
Absolute and relative contraindications of LP include: Skin infection at the site of skin puncture to perform LP, evidence of increased intracranial pressure, any space-occupying lesion in the cranial cavity, trauma, lumbar mass, change in mental capacity, focal nerve deficit, papillary edema, immunocompromised patients, recent seizure or any bleeding disease or coagulation defect
Age
From 1 day old to 24 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
We use the block randomization method to randomize subjects into groups that result in equal sample sizes. At the beginning of the randomization process, we randomly choose one of the following blocks by randomly throwing the dice and divide the rest of the samples into 2 groups according to the order of the samples.
A: intervention and B: control
B A B A 2) B B A A 1)
B A A B 4) A B B A 3)
A A B B 6) A B A B 5)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences, Gorgan,Shastkola road, Philosophical Higher Education Complex
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2022-09-07, 1401/06/16
Ethics committee reference number
IR.GOUMS.REC.1401.259
Health conditions studied
1
Description of health condition studied
Lumbar Puncture
ICD-10 code
G96
ICD-10 code description
Other disorders of central nervous system
Primary outcomes
1
Description
Lumbar Puncture success in first try
Timepoint
Immediately after the intervention
Method of measurement
Lumbar puncture success rate after the first attempt
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: With the help of portable ultrasound, the suitable place for lumbar puncture is marked and then lumbar puncture will be done from that place.
Category
Diagnosis
2
Description
Control group: With classical method, based on anatomical landmarks, lumbar puncture will be performed on control group patients.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr. Leila Barati
Street address
Philosophical Higher Education Complex, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 911 177 7042
Email
atamann1393@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Honarvar
Street address
Philosophical Higher Education, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 911 177 7042
Email
atamann1393@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Prisa Moradi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gprgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
atamann1393@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Parisa Moradi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
atamann1393@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Parisa Moradi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
atamann1393@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD