UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040397
Receipt number R000045805
Scientific Title Prospective cohort study of thermal balneotherapy in infants
Date of disclosure of the study information 2020/06/01
Last modified on 2023/11/16 13:47:13

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Basic information

Public title

Prospective cohort study of thermal balneotherapy in infants

Acronym

Prospective cohort study of thermal balneotherapy in infants

Scientific Title

Prospective cohort study of thermal balneotherapy in infants

Scientific Title:Acronym

Prospective cohort study of thermal balneotherapy in infants

Region

Japan


Condition

Condition

Infant

Classification by specialty

Pediatrics Dermatology Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the effectiveness of balneotherapy on skin function in infants.

Basic objectives2

Others

Basic objectives -Others

To elucidate the association between balneotherapy and sensitization to food allergens in infants.

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Skin function parameters (transepidermal water loss, stratum corneum hydration, and skin pH) at 5 days, 1 month, 4 months, and 12 months of age.

Key secondary outcomes

The eczema area and severity index (EASI) at 5 days, 1 month, 4 months, and 12 months of age and sensitization to food allergens at 12 months of age.


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 days-old <=

Age-upper limit

5 days-old >

Gender

Male and Female

Key inclusion criteria

Singletons delivered at Beppu Medical Center
Neonates born at 37-41 weeks of gestation
Birthweight 2500 g or more
Apgar score at 5 min 8 or more
At least one of the parents with a history of allergic disease

Key exclusion criteria

Congenital abnormalities defines as major anomaly in EUROCAT version 2014
Admission to neonatal intensive care unit (NICU)

Target sample size

26


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Koga

Organization

National Hospital Organization Beppu Medical Center

Division name

Department of Pediatrics

Zip code

874-0011

Address

1473 Oaza Uchikamado, Beppu, Oita, Japan

TEL

+81-977-67-1111

Email

koga.hiroshi.ab@mail.hosp.go.jp


Public contact

Name of contact person

1st name Hiroshi
Middle name
Last name Koga

Organization

National Hospital Organization Beppu Medical Center

Division name

Department of Pediatrics

Zip code

874-0011

Address

1473 Oaza Uchikamado, Beppu, Oita, Japan

TEL

+81-977-67-1111

Homepage URL


Email

koga.hiroshi.ab@mail.hosp.go.jp


Sponsor or person

Institute

Department of Pediatrics, National Hospital Organization Beppu Medical Center

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Hospital Organization Beppu Medical Center

Address

1473 Oaza Uchikamado, Beppu, Oita, Japan

Tel

+81-977-67-1111

Email

kashimoto.takako.cr@mail.hosp.go.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

国立病院機構別府医療センター(大分県)


Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

28

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

No longer recruiting

Date of protocol fixation

2020 Year 05 Month 14 Day

Date of IRB

2020 Year 05 Month 14 Day

Anticipated trial start date

2020 Year 06 Month 01 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry

2024 Year 03 Month 31 Day

Date trial data considered complete

2024 Year 03 Month 31 Day

Date analysis concluded

2024 Year 03 Month 31 Day


Other

Other related information

Skin function parameters and EASI are evaluated at 5 days, 1 month, 4 months, and 12 months of age. Blood tests for sensitization to food allergens are performed at 4 and 12 months of age.


Management information

Registered date

2020 Year 05 Month 14 Day

Last modified on

2023 Year 11 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045805


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name