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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000405
Receipt No. R000000491
Scientific Title Randomized, double-blind, placebo-controlled multi center clinical trial for the prevention of chronic lung disease in extremely low birth weight infants with inhaled fluticasone propionate
Date of disclosure of the study information 2006/04/12
Last modified on 2013/10/30

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Basic information
Public title Randomized, double-blind, placebo-controlled multi center clinical trial for the prevention of chronic lung disease in extremely low birth weight infants with inhaled fluticasone propionate
Acronym Randomized, double-blind, multi center clinical trial for the prevention of chronic lung disease in extremely low birth weight infants with inhaled fluticasone propionate
Scientific Title Randomized, double-blind, placebo-controlled multi center clinical trial for the prevention of chronic lung disease in extremely low birth weight infants with inhaled fluticasone propionate
Scientific Title:Acronym Randomized, double-blind, multi center clinical trial for the prevention of chronic lung disease in extremely low birth weight infants with inhaled fluticasone propionate
Region
Japan

Condition
Condition chronic lung disease in extremely low birth weight infants
Classification by specialty
Pediatrics Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the efficacy and complications of inhaled fluticasone propionate started within 24hours after birth for the prevention of chronic lung disease in Japanese extremely low birth weight infants
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Death or use home oxygen therapy (HOT) for chronic lung disease
Key secondary outcomes 1. Death
2. Death or Incidence of chronic lung disease at 28days
3. Death or Incidence of chronic lung disease at 36 weeks of postmenstrual age
4. Neurological and developmental outcome at 1 and half year old
5. Neurological and developmental outcome at 3 years of age


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Fluticasone propionate inhalation of 50mcg/puff will be given every 12 hours started within 24 hours after birth for 6 weeks or until extubation in extremely low birth weight infants.
Interventions/Control_2 Placebo inhalation (A same dose of Fluticasone propionate of 50mcg/puff) will be given each 12 hours within 24 hours after birth during 6 weeks or until extubation in extremely low birth weight infants.
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
0 weeks-old <=
Age-upper limit
0 weeks-old >=
Gender Male and Female
Key inclusion criteria (1)Extremely Low Birth Weight Infants (weighing less than 1000g at birth)
(2)First inhalation to be given within 24 hours after birth
(3)Mechanical ventilation with intubation (2.5mm and over in tube's diameter)
(4)Informed consent to participate to the study is obtained from the guardians
Key exclusion criteria (1)Subjects with sepsis, pneumonia or severe acute infection
(2)Subjects with severe liver dysfunction.
(3)Subjects with suspected immunodeficiency or abnormal adrenal function.
(4)Subjects with uncontrollable hyperglycemia
(5)Subjects with uncontrollable hypertension
(6)Subjects with severe malformation, highly suspected chromosomal abnormality
(7)Subjects with renal dysfunction.
(8)Subjects judged by the investigator to be inappropriate as study subjects.
Target sample size 211

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiko Nakamura
Organization Nagano Children's Hospital
Division name Division of Neonatology
Zip code
Address 3100 Toyoshina, Azumino city, Nagano, Japan
TEL 0263-73-6700
Email tnakamura@naganoch.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiko Nakamura
Organization Nagano Children's Hospital
Division name Division of Neonatology
Zip code
Address 3100 Toyoshina, Azumino city, Nagano, Japan
TEL 0263-73-6700
Homepage URL http://nrn.shiga-med.ac.jp/
Email tnakamura@naganoch.gr.jp

Sponsor
Institute Neonatal Research Network Japan
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2006 Year 04 Month 12 Day

Related information
URL releasing protocol http://nrn.shiga-med.ac.jp/
Publication of results Unpublished

Result
URL related to results and publications http://nrn.shiga-med.ac.jp/
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 Completed
Date of protocol fixation
2005 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2006 Year 05 Month 01 Day
Last follow-up date
2013 Year 08 Month 01 Day
Date of closure to data entry
2013 Year 08 Month 01 Day
Date trial data considered complete
2013 Year 08 Month 30 Day
Date analysis concluded
2013 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date
2006 Year 04 Month 12 Day
Last modified on
2013 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000491

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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