UMIN-CTR Clinical Trial

Basic information
Public title	Hypoxia inhalation therapy for infants with pulmonary congestion caused by congenital heart disease.
Acronym	Hypoxia inhalation therapy for infants
Scientific Title	Hypoxia inhalation therapy for infants with pulmonary congestion caused by congenital heart disease.
Scientific Title:Acronym	Hypoxia inhalation therapy for infants
Region	Japan

Condition
Condition	hypoplastic left heart syndrome, coarctation of aorta, interruption of aorta, truncus arteriosus, double outlet of right ventricle (Taussig-Bing anomaly), single ventricles
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Patients of congenital heart disease with increased pulmonary blood flow results in reduced systemic blood flow, which may result in shock. Nitrogen inhalation therapy is widely known to be an effective treatment for congestive heart failure due to increased pulmonary blood flow and contribute to improve general conditon. We aimed to analyze this nitrogen inhalation could improve patient condition (blood pressure, stabilize respiratory condition and heart rate, increase urin output, improve acidemia).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	blood pressure, respiratory condition, heart rate, urin output, acidemia, oxygen saturation of peripheral artery
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Hypoxia inhalation nitrogen inhalation
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	365 days-old >
Gender	Male and Female
Key inclusion criteria	HLHS coarctation of aorta, interruption of aorta Truncus arteriosus double outlet of right ventricle single ventricles
Key exclusion criteria	without prior consent of patient's parents
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name KENTARO Middle name Last name UENO
Organization	Kagoshima University Hospital
Division name	Pediatrics
Zip code	8908520
Address	8-35-1 Sakuragaoka, Kagoshima
TEL	099-275-5354
Email	ukenta@m3.kufm.kagoshima-u.ac.jp

Public contact
1st name of contact person	1st name KENTARO Middle name Last name UENO
Organization	Kagoshima University Hospital
Division name	Pediatrics
Zip code	8908520
Address	8-35-1 Sakuragaoka, Kagoshima
TEL	099-275-5354
Homepage URL
Email	ukenta@m3.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Institutional Review Board of Kagoshima University
Institute
Department

Funding Source
Organization	Pediatrics, Kagoshima University Cardiovascular surgery, Kagoshima University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Divisions of clinical trials
Address	8-35-1 Sakuragaoka, Kagoshima
Tel	0992755553
Email	ukenta@m3.kufm.kagoshima-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

Other administrative information
Date of disclosure of the study information	2015 Year 05 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	2015 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date	2015 Year 05 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 04 Month 28 Day
Last modified on	2019 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020081