UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of delayed cord clamping in preterm infants
Title of the study (Brief title)	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	Tomoko Saito
Organization	Niigata University Medical & Dental Hospital
Division name	Perinatal Medical Center
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	Tomoko Saito
Organization	Niigata University Medical & Dental Hospital
Division name	Perinatal Medical Center
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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