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 UMIN000000990
Receipt No. R000001193
Scientific Title A multicenter randomized control study of the effect of umbilical cord milking in avoiding red cell transfusions in extremely immature infants
Date of disclosure of the study information 2008/01/23
Last modified on 2015/07/23

* 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 A multicenter randomized control study of the effect of umbilical cord milking in avoiding red cell transfusions in extremely immature infants
Acronym A multicenter randomized control study of the effect of umbilical cord milking
Scientific Title A multicenter randomized control study of the effect of umbilical cord milking in avoiding red cell transfusions in extremely immature infants
Scientific Title:Acronym A multicenter randomized control study of the effect of umbilical cord milking
Region
Japan

Condition
Condition extremely immature infants
Classification by specialty
Obsterics and gynecology Pediatrics Blood transfusion
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of umbilical cord milking on the need for red blood cell transfusion and neulodevelpomental outcomes in extremely premature infants.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) the probability of not needing transfusion and death
2) amount of blood transfusion within the first 4 weeks
Key secondary outcomes 1) Mortality
2) Major complications (intraventricular hemorrage, chronic lung disease, periventricular leukomalasia, retionopath of prematurity, ontestinal perfolation)
3) serious adverse event
4) hemoglobin values within the first 24 hours
5) stabilization of blood pressure and use of volume expander and/or inotoropes
6) incidence of polycythemia and hyperbilirubinemia
7) developmental disorder at 18 months and 3 years of age (neurodevelopmental delay, cerebral palsy, epilepsy, visual impairment, hearing loss)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 First, umbilical cord is cut and clamped at 30cm from infants. Next the baby is placed on a radiant wormer. Finally, a Pediatrician straightens a kink of the umbilical cord and then milks the umbilical cord steadily once.
Interventions/Control_2 early cord clamping (less than 30 seconds)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) infants born at 24 to less than 28 weeks of gestation
2) informed cocents obtained from parents
Key exclusion criteria 1) Major anomalies diagnosed in utero
2) intrauterin growth retardation ( less than 3SD)
3) monochorionic twins
4) super twin
Target sample size 566

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeharu Hosono
Organization Nihon University School of Medicine
Division name Department of Pediatrics and Child Health
Zip code
Address 30-1 Oyaguchi Itabashi Tokyo Japan
TEL 03-3972-8111(2442)
Email hosono.shigeharu@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeharu Hosono
Organization Nihon University School of Medicine
Division name Department of Pediatrics and Child Health
Zip code
Address 30-1 Oyaguchi Itabashi Tokyo Japan
TEL 03-3972-8111(2442)
Homepage URL http://nrn.shiga-med.ac.jp/milking/
Email hosonos@med.nihon-u.ac.jp

Sponsor
Institute Neonatal Resarch Network
Institute
Department

Funding Source
Organization The Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 君津中央病院(千葉県)、群馬県立小児医療センター(群馬県)、国立成育医療研究センター病院(東京都)、埼玉医科大学総合医療センター(埼玉県)、新潟市民病院(新潟県)、静岡県立こども病院(静岡県)、仙台赤十字病院周産期センター(宮城件)、倉敷中央病院(岡山県)、大垣市民病院(愛知県)、大分県立病院(大分県)、東京医科大学病院(東京都)、東京都立小児総合医療センター(東京都)、日本大学医学部附属板橋病院(東京都)、北海道大学病院(北海道)

Other administrative information
Date of disclosure of the study information
2008 Year 01 Month 23 Day

Related information
URL releasing protocol http://nrn.shiga-med.ac.jp/milking/
Publication of results Unpublished

Result
URL related to results and publications
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 No longer recruiting
Date of protocol fixation
2007 Year 11 Month 29 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2008 Year 01 Month 22 Day
Last modified on
2015 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001193

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.