UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048420 |
|---|---|
| Receipt number | R000055117 |
| Scientific Title | Pathophysiology of bronchopulmonary dysplasia focusing on the IL-33 pathway |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2024/01/21 09:49:44 |
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Basic information
Public title
Pathophysiology of bronchopulmonary dysplasia focusing on the IL-33 pathway
Acronym
Pathophysiology of bronchopulmonary dysplasia focusing on the IL-33 pathway
Scientific Title
Pathophysiology of bronchopulmonary dysplasia focusing on the IL-33 pathway
Scientific Title:Acronym
Pathophysiology of bronchopulmonary dysplasia focusing on the IL-33 pathway
Region
| Japan |
Condition
Condition
Bronchopulmonary dysplasia
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the relationship between the IL-33 pathway and bronchopulmonary dysplasia in preterm infants.
Basic objectives2
Others
Basic objectives -Others
To clarify the role of cytokines such as IL-6, IL-8, VEGF, and TNF-alpha in the acute phase as biomarkers of bronchopulmonary dysplasia.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum IL-33 concentration at corrected 36 weeks
Key secondary outcomes
IL-33 pathway IL-4, IL-5, IL-13, TSLP at corrected 36 weeks; IL-6, IL-8, VEGF, TNF-alpha and other cytokines in the acute phase.
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
| 4 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Preterm infants born at less than 30 weeks gestation requiring ventilatory support such as ventilatory mechanical ventilation, continuous positive airway pressure, high flow nasal cannula etc.
Key exclusion criteria
congenital multiple malformation syndrome, chromosome abnormalities, congenital airway malformations
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Maki |
| Middle name | |
| Last name | Urushihara |
Organization
Tokushima University Hospital
Division name
Department of pediaircs
Zip code
770-8503
Address
Kuramotocho-3chome 18-15, Tokushima City
TEL
+81-88-633-7135
urushihara@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Suga |
Organization
Tokushima University Hospital
Division name
Department of pediatrics
Zip code
770-8503
Address
Kuramotocho-3chome 18-15, Tokushima City
TEL
+81-88-633-7135
Homepage URL
suga.kenichi.1@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Tokushima University Hospital
Address
Kuramotocho-3chome 18-15, Tokushima City
Tel
+81-88-633-9294
awachiken@tokushima-u.ac.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
香川大学（香川県）高知大学（高知県）愛媛大学(愛媛県)
四国こどもとおとなの医療センター(香川県)高知医療センター（高知県）
愛媛県立中央病院（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-mail c-akiyoshi-shin@eph.pref.ehime.jp
The purpose of this study is to clarify the association between the development of bronchopulmonary dysplasia in preterm infants and cytokines in the IL-33 pathway. In a collaborative study with major NICU facilities in Shikoku, we will compare serum IL-33 concentrations at corrected 36 weeks between groups of preterm infants requiring respiratory support who are born at less than 30 weeks' gestation and those who does not develop chronic lung disease as the primary endpoint. The secondary endpoint will be the IL-33 pathway including IL-4, IL-5, IL-13, and TSLP at 36 weeks by multiplex assay. Cytokines such as IL-6, IL-8, VEGF, and TNF-alpha in the acute phase will also be examined as biomarkers of bronchopulmonary dysplasia . If the relationship between IL-33 pathway and bronchopulmonary dysplasia is clarified by this study, IL-33 antibody (Itepekimab) and IL-4/13 antibody (Dupilumab) targeting IL-33 pathway may be candidates for treatment and may improve the prognosis of bronchopulmonary dysplasia .
Management information
Registered date
| 2022 | Year | 07 | Month | 21 | Day |
Last modified on
| 2024 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055117
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