UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026456 |
|---|---|
| Receipt number | R000030377 |
| Scientific Title | Effects of delayed cord clamping in preterm infants |
| Date of disclosure of the study information | 2017/03/08 |
| Last modified on | 2017/03/08 10:29:28 |
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Basic information
Public title
Effects of delayed cord clamping in preterm infants
Acronym
Delayed cord clamping in preterm infants
Scientific Title
Effects of delayed cord clamping in preterm infants
Scientific Title:Acronym
Delayed cord clamping in preterm infants
Region
| Japan |
Condition
Condition
preterm infants
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of delayed cord clamping vs immediate cord clamping on systemic blood flow, jaundice, neurodevelopment. and preventing anemia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Hemoglobin level in birth and the necessity of blood transfusion in the first month of life
2) the need for phototherapy to treat jaundice.
Key secondary outcomes
1) the safety of resuscitation of neonate(Apgar score, the time to initial cry, initial temperature on admission)
2) systematic blood flow in birth (blood pressure, SVC flow, urine output in the first day of life)
3) mobidity and mortality
4) transition of hemoglobin level and strage iron
5) neurodevelopment outcome at 18months and 36 months.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
delayed cord clamping
Interventions/Control_2
Waiting for 30-60 seconds before clamping the cord
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
| 0 | years-old | <= |
Age-upper limit
| 0 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
preterm infant at 29 to 35 weeks gestation.
Key exclusion criteria
monochorionic multiples
placenta previa
congenital anomalies
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoko Saito |
Organization
Niigata University Medical & Dental Hospital
Division name
Perinatal Medical Center
Zip code
Address
1-754 Asahimachidori Chuo-ku Niigata-shi Niigata
TEL
025-227-2222
kou309@pop21.odn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Saito |
Organization
Niigata University Medical & Dental Hospital
Division name
Perinatal Medical Center
Zip code
Address
1-754 Asahimachidori Chuo-ku Niigata-shi Niigata
TEL
025-227-2222
Homepage URL
kou309@pop21.odn.ne.jp
Sponsor or person
Institute
Niigata University Medical & Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2017 | Year | 03 | Month | 08 | 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
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 08 | Day |
Last modified on
| 2017 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030377
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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