Evidence based prevention of cerebral palsy in preterm infants

Evidence based prevention of cerebral palsy in preterm infants - EPOC study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008213

Enrollment

462

Registered

2012-06-20

Start date

2012-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral palsy in preterm infants

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Incidence of CP or death at 1 year old to 1 year and half in corrected age	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactIneko Kato

Saitama Medical Center, Saitama Medical University Department of Neonatology, Center of Maternal, Fetal and Neonatal Medicine

epoc@saitama-med.ac.jp0492-28-3400

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026