NCT01732146

Brief Summary

The purpose of this study is to determine the efficacy of high dose Erythropoietin to improve survival and neurologic outcome in asphyxiated term newborn undergoing cooling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

March 28, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2017

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

3.9 years

First QC Date

November 19, 2012

Last Update Submit

November 17, 2025

Conditions

Hypoxic Ischemic Encephalopathy

Keywords

Hypoxic Ischemic EncephalopathyTerm neonateNeuroprotectionerythropoietin

Outcome Measures

Primary Outcomes (1)

  • Survival without neurologic sequelae

    at 24 months

Secondary Outcomes (4)

  • Mortality rates

    Within 24 months

  • Rate of moderate and severe sequelae

    at 24 months

  • Aspect of brain lesions on MRI

    at day 6 and day 12 after birth

  • Tolerance of treatment

    at 24 months

Study Arms (2)

Erythropoietin beta

ACTIVE COMPARATOR

1000 to 1500 U/kg/dose X 3 every 24 hours

Drug: erythropoietin Beta

Placebo

PLACEBO COMPARATOR

0.2 ml saline solution X 3 given every 24 hours

Drug: Placebo

Interventions

erythropoietin BetaDRUG

erythropoietin intravenous injection (5000 U/ 0.3 ml)1000 to 1500 U/kg/dose X 3 given every 24 hours with the first dose within 12 hours of delivery

Erythropoietin beta
PlaceboDRUG
Also known as: 0.2 ml saline solution X 3 given every 24 hours with the first dose within 12 hours of delivery
Placebo

Eligibility Criteria

AgeUp to 12 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Term or near-term newborn (\> = 36 weeks gestational age)
  • Moderate to severe encephalopathy
  • undergoing moderate controlled hypothermia started within 6 hours after delivery : rectal or esophageal temperature maintained at 33.5 ° C + / - 0.5 ° C before H6
  • Beneficiary of social security plan
  • Informed consent parental authority

You may not qualify if:

  • Impossibility of getting controlled hypothermia before H6
  • Infant older than 12 hours of age
  • Chromosomal or significant congenital abnormality
  • Predictable surgery in the first 3 days of life
  • Uncontrolled collapse
  • Haemorrhagic syndrome unchecked
  • Head trauma with or without skull fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital

Paris, 75014, France

Location

Related Publications (2)

  • Zhu C, Kang W, Xu F, Cheng X, Zhang Z, Jia L, Ji L, Guo X, Xiong H, Simbruner G, Blomgren K, Wang X. Erythropoietin improved neurologic outcomes in newborns with hypoxic-ischemic encephalopathy. Pediatrics. 2009 Aug;124(2):e218-26. doi: 10.1542/peds.2008-3553. Epub 2009 Jul 27.

    PMID: 19651565BACKGROUND

  • Goodarzi MO, Carmina E, Azziz R. DHEA, DHEAS and PCOS. J Steroid Biochem Mol Biol. 2015 Jan;145:213-25. doi: 10.1016/j.jsbmb.2014.06.003. Epub 2014 Jul 5.

    PMID: 25008465BACKGROUND

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Parturition

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnancyReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Juliana Patkai, MD, PhD

    Cochin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2012

First Posted

November 22, 2012

Study Start

March 28, 2013

Primary Completion

February 14, 2017

Study Completion

February 14, 2017

Last Updated

November 20, 2025

Record last verified: 2025-10

Locations

FR(1)