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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000048420 |
Receipt No. | 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 | 2022/07/21 |
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 |
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Condition | ||
Condition | Bronchopulmonary dysplasia | |
Classification by specialty |
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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 | |
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Blocking | |
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Eligibility | ||||
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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 |
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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 |
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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 | |
Institute | Tokushima University Hospital |
Institute | |
Department |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Preinitiation | ||||||
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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 . |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055117 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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