UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007064
Receipt number 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 2020/01/20 15:48:31

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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

1 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

Name of lead principal investigator

1st name Satoshi
Middle name
Last name Kusuda

Organization

Materanal & Perinatal Center
Tokyo Women's Medical University

Division name

Neonatology

Zip code

1620054

Address

8-1 Kawadacho, Shinjuku, Tolyo

TEL

03-5269-7344

Email

kusuda-satoshi@umin.ac.jp


Public contact

Name of contact person

1st name Toshihiko
Middle name
Last name Nishida

Organization

National Center for Child Health and Development

Division name

INTACT support office, Department of Health Policy

Zip code

1570074

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 or person

Institute

Tokyo Women's Medical University

Institute

Department

Personal name



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

Central IRB, Intact study

Address

8-1 Kawadacho, Shinjuku, Tokyo

Tel

03-5269-7344

Email

kusuda-satoshi@umin.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

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

2011 Year 07 Month 15 Day

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

2020 Year 01 Month 20 Day



Link to view the page

Value
https://center6.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