UMIN-CTR Clinical Trial

Public title

REAL-TIME REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION DETECTION OF CONGENITAL RUBELLA INFECTION IN INFANTS USING SALIVA

Acronym

REAL-TIME REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION DETECTION OF CONGENITAL RUBELLA INFECTION IN INFANTS USING SALIVA

Scientific Title

REAL-TIME REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION DETECTION OF CONGENITAL RUBELLA INFECTION IN INFANTS USING SALIVA

Scientific Title:Acronym

REAL-TIME REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION DETECTION OF CONGENITAL RUBELLA INFECTION IN INFANTS USING SALIVA

Region

Japan

Condition

Congenital rubella infection

Classification by specialty

Infectious disease	Pediatrics	Child

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We therefore investigated the incidence of aCRI in infants in Tokyo by screening saliva samples for the rubella virus.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Positive result of real-time PCR for rubella virus in infant's saliva

Key secondary outcomes

Their mothers had caught rubella, and taken rubella vaccine, and exposed a rubella patient

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Saliva test on infant

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

Age-lower limit

Not applicable

Age-upper limit

2

months-old

>

Gender

Male and Female

Key inclusion criteria

All infants who were born in the hospitals, or visit to these

Key exclusion criteria

Subject who rejected to join in this study, or
who had been confirmed as rubella infection by amniotic fluid test, or
who had fever or rash if acute rubella infection had been not ruled out

Target sample size

300

Name of lead principal investigator

1st name
Middle name
Last name	Kei Yamamoto

Organization

National Center for Global Health and Medicine

Division name

Disease control and prevention center

Zip code

Address

1-21-1 Toyama, Shinjuku-ku

TEL

+81332027181

Email

nicepoko@gmail.com

Name of contact person

1st name
Middle name
Last name	Kei Yamamoto

Organization

National Center for Global Health and Medicine

Division name

Disease control and prevention center

Zip code

Address

1-21-1 Toyama, Shinjuku-ku

TEL

+81332027181

Homepage URL

Email

nicepoko@gmail.com

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name

Organization

Japan Foundation for Pediatric Research

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Department of Pediatrics, National Center for Global Health and Medicine
Karugamo Clinic
Hosobe Clinic of Pediatrics
Matsudaira Clinic of Pediatrics
Wada Clinic of Pediatrics
Department of Pediatrics, Kawakita General
Hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

独立行政法人国立国際医療研究センター病院（東京都）
かるがもクリニック（東京都）
細部小児科クリニック（東京都）
松平小児科（東京都）
和田小児科医院（東京都）
河北総合病院（東京都）

Date of disclosure of the study information

2015

Year

07

Month

29

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Of 213 enrolled infants, data were obtained from 195 (96 males). Their median age was 6 days (interquartile range [IQR]: 5 to 31 days) and their median gestation week (n=181) was 39.4 (IQR 38.3 to 40.1).
Sufficient volume (>200 uL) was obtained from 117 samples, and 78 samples had small volumes (100 to 200 uL, n = 41; 50 to 100 uL, n = 19; <50 uL, n = 18). All PCR tests were negative.

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

Recruitment status

Completed

Date of protocol fixation

2014

Year

01

Month

17

Day

Date of IRB

Anticipated trial start date

2014

Year

02

Month

01

Day

Last follow-up date

2014

Year

12

Month

31

Day

Date of closure to data entry

2015

Year

04

Month

20

Day

Date trial data considered complete

2015

Year

05

Month

18

Day

Date analysis concluded

Other related information

Median age of mother was 34 years (IQR 30-37 years, n = 194). Of them, 90 mothers describe antibody titers of rubella (Hemagglutination Inhibition Test) during this pregnancy. Twenty nine mothers should receive rubella vaccine after delivery (2 had less than 1:8, 27 had 1:8 to 16).
Sixty nine mothers had a history of rubella infection. Of them, 2 mothers were diagnosed as rubella infection during this pregnancy.

Registered date

2015

Year

07

Month

29

Day

Last modified on

2015

Year

07

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021241