UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007064
Receipt No. R000007185
Scientific Title Improvement of NICU practice and team approach cluster randomaized controlled trial
Date of disclosure of the study information 2012/02/01
Last modified on 2017/07/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Improvement of NICU practice and team approach cluster randomaized controlled trial
Acronym INTACT
Scientific Title Improvement of NICU practice and team approach cluster randomaized controlled trial
Scientific Title:Acronym INTACT
Region
Japan

Condition
Condition Very low birth weight infants
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Improvement of the intact survival proportion among low birth weight infants at 1.5 and 3 years of age
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes intact survival at 3 years of age
Key secondary outcomes mortality at day 28 after birth
mortality at 1 year of age
mortality at 1.5 year age
intact survival at 1.5 year of age
neurological development at 1.5 year of age
mortality at 3 year of age
neurological development at 3 year of age
morbilities during admission
(related guideline, non-related)
Process indicator related guideline and intervention
Quality of Life

<Medical staff>
Oeganization cluture scale
In organization human relationship scale
Occupational Satisfaction
SPRAT scale
Occupational Stress
Burnout scale
Office hours

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment Behavior,custom Maneuver
Interventions/Control_1 Workshop and outreach education with 2 clinical guidelines selceted according to the analysis of each participating hospital background data resgistered 3 years prior to the intervention
Interventions/Control_2 control
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

Not applicable
Age-upper limit
0 weeks-old >
Gender Male and Female
Key inclusion criteria Very low birht weight infants with birth weight between 400 and 1500g admitted on day 0
Key exclusion criteria Still birth
Target sample size 2800

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Satoshi Kusuda
Organization Materanal & Perinatal Center
Tokyo Women's Medical University
Division name Neonatology
Zip code
Address 8-1 Kawadacho, Shinjuku, Tolyo
TEL 03-5269-7344
Email kusuda-satoshi@umin.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Toshihiko Nishida
Organization National Center for Child Health and Development
Division name INTACT support office, Department of Health Policy
Zip code
Address 2-10-1 Ookura, Setagaya, Tokyo
TEL 03-3416-0181
Homepage URL http://www.nicu-intact.org/
Email nishida-t@ncchd.go.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funder(s) Ministry of Health, Labour, and Welfare

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 青森県立中央病院(青森県)、秋田大学病院(秋田県)、埼玉医科大学総合医療センター(埼玉県)、川口市立医療センター(埼玉県)、日本大学板橋病院(東京都)、国立成育医療研究センター(東京都)、聖路加国際病院(東京都)、横浜労災病院(神奈川県)、山梨県立中央病院(山梨県)、長野県立こども病院(長野県)、信州大学病院(長野県)、新潟大学病院(新潟県)、新潟市民病院(新潟県)、石川県立中央病院(石川県)、福井県立病院(福井県)、岐阜県総合医療センター(岐阜県)、聖隷浜松病院(静岡県)、静岡県立こども病院(静岡県)、浜松医科大学病院(静岡県)、名古屋第一赤十字病院(愛知県)、名古屋第二赤十字病院(愛知県)、国立病院機構三重中央医療センター(三重県)、伊勢赤十字病院(三重県)、日本バプテスト病院(京都府)、大阪府立母子保健総合医療センター(大阪府)、高槻病院(大阪府)、愛染橋病院(大阪府)、市立豊中病院(大阪府)、北野病院(大阪府)、済生会吹田病院(大阪府)、和歌山県立医科大学病院(和歌山県)、鳥取大学病院(鳥取県)、倉敷中央病院(岡山県)、国立病院機構岡山医療センター(岡山県)、広島市立広島市民病院(広島県)、県立広島病院(広島県)、高知県・高知市企業団立高知医療センター(高知県)、久留米大学病院(福岡県)、国立病院機構長崎医療センター(長崎県)、熊本市立熊本市民病院(熊本県)

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 01 Day

Related information
URL releasing protocol http://www.nicu-intact.org/
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Number of registered infants has reached at about 3400 in February, 2014.
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 No longer recruiting
Date of protocol fixation
2011 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 12 Day
Last follow-up date
2017 Year 03 Month 01 Day
Date of closure to data entry
2017 Year 12 Month 01 Day
Date trial data considered complete
2017 Year 12 Month 01 Day
Date analysis concluded
2018 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 01 Month 13 Day
Last modified on
2017 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007185

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.