UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000990 |
|---|---|
| Receipt number | 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 10:40:43 |
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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
| Obstetrics 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)
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/
hosonos@med.nihon-u.ac.jp
Sponsor or person
Institute
Neonatal Resarch Network
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001193
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| Registered date | File name |
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