UMIN-CTR Clinical Trial

Public title

Evidence based prevention of cerebral palsy in preterm infants

Acronym

EPOC study

Scientific Title

Evidence based prevention of cerebral palsy in preterm infants

Scientific Title:Acronym

EPOC study

Region

Japan

Condition

Cerebral palsy in preterm infants

Classification by specialty

Obstetrics and Gynecology

Pediatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Prevention of preterm cerebral palsy by erythropoietin

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

Incidence of CP or death at 1 year old to 1 year and half in corrected age

Key secondary outcomes

1) Incidence of PVL at 28 days and 1 year old to 1 year and half in corrected age
2) Severity of CP at 1 year old to 1 year and half in corrected age
3) Complete blood counts, liver function, renal function, blood sugar and blood pressure at 7 and 28 days
4) Incidence of Late-onset circulatory disorder within 28 days
5) Incidence of symptomatic patent ductus arteriosus within 28 days
6) Incidence of intracranial hemorrhage (Level 3-4) within 28 days
7) Administration of EPO for the improvement of anemia of prematurity within 28 days
8) Mortality at 1 year old to 1 year and half in corrected age

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

We administer one dose of erythropoietin intravenously within twelve hours (within six hours is desirable) after birth.

Interventions/Control_2

We administer one dose of placebo intravenously within twelve hours (within six hours is desirable) after birth.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) A premature baby less than 33 weeks and more than 25 weeks for gestational ages, and following 2) is satisfied.
2) when either of following a) or b) is satisfied.
a) Within one hour before birth, CTG reveals one of the following findings over 50% of each uterine contraction.
#Moderate or Severe Variable Deceleration (severe Variable Deceleration in the obstetric guideline)
#Prolonged Deceleration (from two to ten miniutes)
#Bradycardia (more than ten minutes)
b) Within one week before birth, there are fever more than 38 degrees Celsius of the mother and one of the following inflammatory findings.
#Meconium turbidity
#Maternal white-cell count more than 20,000/mm3
#Maternal CRP more than 2mg/dl.
#Maternal (more than 100bpm) or fetal (more than 160bpm) tachycardia.

Key exclusion criteria

1) Congenital anomaly (the accurate neurological abnormality and severe heart malformation)
2) Chromosomal aberration
3) Hydrops foetalis
4) IUGR (less than -3.0SD)
5) Severe asphyxia
6) The case found PVL at birth
7) The case that is understood inappropriate by doctors

Target sample size

462

Name of lead principal investigator

1st name
Middle name
Last name	Hajime Togari

Organization

Nagoya City University

Division name

Administration Office

Zip code

Address

1, Kawasumi, Mizuho, Nagoya

TEL

0492-28-3400

Email

epoc@saitama-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Ineko Kato

Organization

Saitama Medical Center, Saitama Medical University

Division name

Department of Neonatology, Center of Maternal, Fetal and Neonatal Medicine

Zip code

Address

1981 Kamoda, Kawagoe, Saitama

TEL

0492-28-3400

Homepage URL

Email

epoc@saitama-med.ac.jp

Institute

EPOC study group

Institute

Department

Personal name

Organization

Japan Kidney Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

06

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2012

Year

06

Month

28

Day

Date of IRB

Anticipated trial start date

2012

Year

07

Month

01

Day

Last follow-up date

2016

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

06

Month

19

Day

Last modified on

2015

Year

06

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009643