UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053202 |
|---|---|
| Receipt number | R000060720 |
| Scientific Title | Neonatal gastric tube tip position verification using light-emitting diode source and fiber: multicenter study (GATU-LED study) |
| Date of disclosure of the study information | 2023/12/22 |
| Last modified on | 2023/12/22 20:39:12 |
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Basic information
Public title
Neonatal gastric tube tip position verification using light-emitting diode source and fiber: multicenter study
Acronym
Neonatal gastric tube tip position verification using light-emitting diode source and fiber: multicenter study (GATU-LED study)
Scientific Title
Neonatal gastric tube tip position verification using light-emitting diode source and fiber: multicenter study (GATU-LED study)
Scientific Title:Acronym
Neonatal gastric tube tip position verification using light-emitting diode source and fiber: multicenter study (GATU-LED study)
Region
| Japan |
Condition
Condition
Infant in Need of a Gastric Tube in the Neonatal Intensive Care Unit (NICU)
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to assess the effectiveness of utilizing LED technology for the rapid, safe, and precise confirmation of the tip position of a nasogastric tube.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy Assessment of the Inserted Nasogastric Tube Tip Position Using LED Device: Proportion of Tubes Positioned at Location 3, with X-ray Evaluation as the Golden Standard
Key secondary outcomes
Comparison Nasogastric Tube Insertion Lengths Determined by LED Device, Insertion Length Calculated Based on Height, Insertion Length Calculated Based on Weight.
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
| Not applicable |
Age-upper limit
| 1 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Infants requiring the insertion of a gastric tube in Neonatal intensive care unit of the research facilities.
2. An X-ray is scheduled to take after the gastric tube insertion.
3. Consent to participate in the research based on the free will of the representative after receiving sufficient explanation.
Key exclusion criteria
1. Complications requiring surgery in the route from the nasal cavity or oral cavity to the stomach (e.g., esophageal atresia, esophageal hiatal hernia, tracheoesophageal cleft)
2. The research director or co-researcher deems inappropriate as a research subject.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Okazaki |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Neonatology
Zip code
183-8561
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
+81-42-300-5111
kaoru_okazaki@tmhp.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Okazaki |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Neonatology
Zip code
183-8561
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
+81-42-300-5111
Homepage URL
kaoru_okazaki@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
No
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
Tokyo Metropolitan Children's Medical Center
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
Tel
+81-42-300-5111
sn_chiken-jimu@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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After inserting the gastric tube using an LED device, the position of the tube's tip is confirmed through X-ray imaging to assess whether it is in the correct position.
Management information
Registered date
| 2023 | Year | 12 | Month | 22 | Day |
Last modified on
| 2023 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060720
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
