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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026456
Receipt No. 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

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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
Email 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
Email kou309@pop21.odn.ne.jp

Sponsor
Institute Niigata University Medical & Dental Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030377

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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