UMIN-CTR Clinical Trial

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
Email	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
Email	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
Email	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	Preinitiation
Date of protocol fixation	2022 Year 07 Month 20 Day
Date of IRB
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	2022 Year 07 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055117

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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