UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013296 |
|---|---|
| Receipt number | 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 | 2023/03/06 12:04:17 |
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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
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
akio-i@k4.dion.ne.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014894
