UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044275 |
|---|---|
| Receipt number | R000050560 |
| Scientific Title | Ultrasound imaging for diagnostic lumbar puncture for infants 90 days and younger |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2023/05/22 20:29:28 |
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Basic information
Public title
Ultrasound imaging for diagnostic lumbar puncture for infants 90 days and younger
Acronym
Ultrasound imaging for diagnostic lumbar puncture for infants 90 days and younger
Scientific Title
Ultrasound imaging for diagnostic lumbar puncture for infants 90 days and younger
Scientific Title:Acronym
Ultrasound imaging for diagnostic lumbar puncture for infants 90 days and younger
Region
| Japan |
Condition
Condition
lumbar puncture
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify efficacy of ultrasound imaging performed by the operator of lumber puncture in infants 90 days and younger in obtaining clear cerebrospinal fluid
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
success rate in obtaining clear cerebrospinal fluid by ultrasound-assisted lumbar puncture
Key secondary outcomes
traumatic tap rate
success rate for clear cerebrospinal fluid on the first attempt
Comparison in the following items between the two groups, ultrasound imaging versus palpation method: success rate for clear cerebrospinal fluid, success rate for clear cerebrospinal fluid on the first attempt, traumatic tap rate, elapsed time for ultrasound imaging.
Associations among the successful ultrasound-assisted lumbar puncture and the following factors; local anesthesia, early-stylet removal technique, elapsed time for ultrasound-imaging, the number of attempts, age, body weight, consciousness, body movement in the process of lumbar puncture, experience of the operator as a pediatrician, spinal canal depth, and puncture depth deeper than the measured one from skin to anterior spinal canal.
Association between depth of spinal canal and child's length or weight, association between the depth of a needle where cerebrospinal fluid is obtained and the measured one, and the predictive formula of depth of spinal canal by using explanation variables such as weight or length.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | days-old | <= |
Age-upper limit
| 90 | days-old | > |
Gender
Male and Female
Key inclusion criteria
Patients at emergency department in Tokyo Metropolitan Children Medical Center in the period of from June to November in 2021, who satisfy all the criterion below and are not applicable for the exclusion criterion.
age younger than 90 days when the patient presents at the emergency department
patients who were required lumbar puncture by doctors
ultrasound imaging conducted by those who had passed the program of ultrasound-assisted lumbar puncture
both ultrasound imaging and lumbar puncture were carried out by the same doctor
Key exclusion criteria
lumbar puncture conducted at the different lumber space from the space observed with ultrasonography
those whom doctors decided be inapplicable in this study
those who denied to join this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Metropolitan Children Medical Center
Division name
Department of General Pediatrics
Zip code
183-8561
Address
2-8-29 Musashidai, Fuchu, Tokyo
TEL
042-300-5111
satoko_suzuki@tmhp.jp
Public contact
Name of contact person
| 1st name | Rei |
| Middle name | |
| Last name | Miyake |
Organization
Tokyo Metropolitan Children Medical Center
Division name
Department of General Pediatrics
Zip code
183-8561
Address
2-8-29 Musashidai, Fuchu, Tokyo
TEL
042-300-5111
Homepage URL
rei_miyake@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Children Medical Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethics committee of Tokyo Metropolitan Children's Medical Center
Address
2-8-29 Musashidai, Fuchu, Tokyo
Tel
042-300-5111
sn_rinri@tmhp.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京都立小児総合医療センター(東京都)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation study
Management information
Registered date
| 2021 | Year | 05 | Month | 20 | Day |
Last modified on
| 2023 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050560
