UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013296
Receipt No. R000014894
Scientific Title Blood pressure-oriented versus blood flow-oriented circulatory management for preventing intraventricular hemorrhage in VLBW infants during first 7 days: a randomized trial
Date of disclosure of the study information 2014/03/31
Last modified on 2021/10/29

* 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 Blood pressure-oriented versus blood flow-oriented circulatory management for preventing intraventricular hemorrhage in VLBW infants during first 7 days: a randomized trial
Acronym Blood pressure-oriented versus blood flow-oriented circulatory management for preventing intraventricular hemorrhage in VLBW infants
Scientific Title Blood pressure-oriented versus blood flow-oriented circulatory management for preventing intraventricular hemorrhage in VLBW infants during first 7 days: a randomized trial
Scientific Title:Acronym Blood pressure-oriented versus blood flow-oriented circulatory management for preventing intraventricular hemorrhage in VLBW infants
Region
Japan

Condition
Condition cardiovascular failure in very low birth weight infants
Classification by specialty
Pediatrics Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether blood flow-oriented circulatory management in VLBW infants during the first 7 days decrease intraventricular hemorrhage, cerebral palsy and developmental delay compared with the conventional blood pressure-oriented circulatory management.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes incidence proportion of intraventricular hemorrhage
Key secondary outcomes 1. mortality during neonatal period
2. mortality at 1 year of age
3. incidence proportion of periventricular leukomalacia
4. incidence proportion of necrotizing enterocolitis
5. incidence proportion of retinopathy of prematurity
6. proportion of infants who received any kinds of circulatory support
7. proportion of infants who could not achieve the goal of therapies (blood pressure or blood flow)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 blood pressure-oriented group:
administering circulatory agent aiming to keep blood pressure above the number of gestational age
Interventions/Control_2 blood flow-oriented group:
administering circulatory agent aiming to keep blood flow above the cut-off values obtained by previous study
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
3 years-old >=
Gender Male and Female
Key inclusion criteria Very low birth weight infant (less than 1500g of birth weight)
Key exclusion criteria chromosomal anomaly
major anomaly
congenital heart disease
severe asphyxia
Gestationalage less than 22 weeks
Target sample size 440

Research contact person
Name of lead principal investigator
1st name Akio
Middle name
Last name Ishiguro
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Pediatrics
Zip code 3508550
Address 1981 kamoda, Kawagoe, Saitama, Japan6
TEL +81-049-228-3890
Email akio-i@k4.dion.ne.jp

Public contact
Name of contact person
1st name Akio
Middle name
Last name Ishiguro
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Pediatrics
Zip code 3508550
Address 1981 kamoda, Kawagoe, Saitama, Japan
TEL +81-049-228-3890
Homepage URL
Email akio-i@k4.dion.ne.jp

Sponsor
Institute Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization Ministry of Education
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 Saitama Medical Center
Address Kamoda1981, Kawagoe, Saitama
Tel +81-049-228-3890
Email Furuki@saitama-med.ac.jp

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 埼玉医大総合医療センター 総合母子周産期センター(埼玉県)

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 31 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
2013 Year 12 Month 17 Day
Date of IRB
2014 Year 04 Month 01 Day
Anticipated trial start date
2014 Year 05 Month 08 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 27 Day
Last modified on
2021 Year 10 Month 29 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014894

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.