UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025030
Receipt number R000028803
Scientific Title Clinical investigation on new babies with cleft lip and/or palate in JAPAN from 2013 to 2014
Date of disclosure of the study information 2016/12/01
Last modified on 2023/12/06 17:44:29

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Basic information

Public title

Clinical investigation on new babies with cleft lip and/or palate in JAPAN from 2013 to 2014

Acronym

Clinical investigation on CLP in JAPAN

Scientific Title

Clinical investigation on new babies with cleft lip and/or palate in JAPAN from 2013 to 2014

Scientific Title:Acronym

Clinical investigation on CLP in JAPAN

Region

Japan


Condition

Condition

Cleft lip and/or palate

Classification by specialty

Obstetrics and Gynecology Pediatrics Oral surgery
Plastic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the recent condition on cleft palate patients in association with introduction of prenatal diagnosis or decreasing new birth.

Basic objectives2

Others

Basic objectives -Others

To clarify the birth rate and condition of cleft lip and/or palate.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

body weight at birth, prenatal diagnosis, apgar score, mother's age, cleft type, cleft site, systemic conditions

Key secondary outcomes

To improve the management plans and it's explanation to the family.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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 years-old <=

Age-upper limit

2 years-old >=

Gender

Male and Female

Key inclusion criteria

Cleft lip and/or palate

Key exclusion criteria

without cleft lip and/or palate

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takagi Ritsuo

Organization

Niigata University, Graduate School of Medical and Dental Sciences.

Division name

Oral and Maxillofacial Surgery

Zip code


Address

2-5274 Gakko-cho dori, Chu-oh ku, Niigata ciy

TEL

+81-25-227-2883

Email

takagi@dent.niigata-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takagi Ritsuo

Organization

Japanese Cleft Palate Association

Division name

Academic Survey Committee

Zip code


Address

2-4-11 Fukagaw, Kotoh ku, Tokyo

TEL

+81-3-5620-1953

Homepage URL

http://square.umin.ac.jp/jclp/

Email

jclp-service@onebridge.co.jp


Sponsor or person

Institute

Niigata University, Graduate School of Medical and Dental Sciences.
Div. of Oral and Maxillofacial Surgery.

Institute

Department

Personal name



Funding Source

Organization

Japanese Cleft Palate Association

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


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

2016 Year 12 Month 01 Day


Related information

URL releasing protocol

http://square.umin.ac.jp/jclp/index.htm

Publication of results

Unpublished


Result

URL related to results and publications

http://square.umin.ac.jp/jclp/index.htm

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

2017 Year 01 Month 01 Day

Date of IRB

2020 Year 05 Month 29 Day

Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry

2017 Year 03 Month 31 Day

Date trial data considered complete

2017 Year 05 Month 01 Day

Date analysis concluded

2017 Year 05 Month 31 Day


Other

Other related information

The data of patients with CLP from each hospital are anonymous, therefore, it is impossible to know the patient name from the data. (The academic survey committee of Japanese Cleft Palate Association)


Management information

Registered date

2016 Year 11 Month 28 Day

Last modified on

2023 Year 12 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028803


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name