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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name