UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000405
Receipt number 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 15:29:08

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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 or person

Institute

Neonatal Research Network Japan

Institute

Department

Personal name



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

Value
https://center6.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