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Efficacy of Erythropoietin to Improve Survival and Neurological Outcome in Hypoxic Ischemic Encephalopathy (Neurepo)

Primary Purpose

Hypoxic Ischemic Encephalopathy

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
erythropoietin Beta
Placebo
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxic Ischemic Encephalopathy focused on measuring Hypoxic Ischemic Encephalopathy, Term neonate, Neuroprotection, erythropoietin

Eligibility Criteria

undefined - 12 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Cochin Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Erythropoietin beta

Placebo

Arm Description

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

0.2 ml saline solution X 3 given every 24 hours

Outcomes

Primary Outcome Measures

Survival without neurologic sequelae

Secondary Outcome Measures

Mortality rates
number of dead patients
Rate of moderate and severe sequelae
Mental Developmental index (Brunet Lezine Test), motor, visual and hearing impairment
Aspect of brain lesions on MRI
Brain MRI performed between day 6 and day 12 after birth
Tolerance of treatment

Full Information

First Posted
November 19, 2012
Last Updated
April 30, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01732146
Brief Title
Efficacy of Erythropoietin to Improve Survival and Neurological Outcome in Hypoxic Ischemic Encephalopathy
Acronym
Neurepo
Official Title
Phase III Study of Efficacy of High Dose Erythropoietin to Prevent Hypoxic-ischemic Encephalopathy Sequelae in Term Newborn
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 28, 2013 (Actual)
Primary Completion Date
February 14, 2017 (Actual)
Study Completion Date
February 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Hypoxic-ischemic encephalopathy remains the main cause of death or long term neurologic impairments in neonates. Yet, therapies for birth asphyxia are currently limited. Hypothermia when applied within 6 hours after birth demonstrate partial improvement in outcome of newborns specially those with moderate form. Erythropoietin and its receptors are upregulated after brain injury in ischemic conditions. Systemically administered erythropoietin is neuroprotective in animal models of birth asphyxia. To date, one study demonstrate improvement neurologic outcome in asphyxiated term newborn under erythropoietin treatment but no reports evaluating beneficial of erythropoietin associated with cooling. This is a large randomised controlled trial to evaluate the efficacy of high dose erythropoietin on outcome at two years of asphyxiated term newborns undergoing cooling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic Ischemic Encephalopathy
Keywords
Hypoxic Ischemic Encephalopathy, Term neonate, Neuroprotection, erythropoietin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erythropoietin beta
Arm Type
Active Comparator
Arm Description
1000 to 1500 U/kg/dose X 3 every 24 hours
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.2 ml saline solution X 3 given every 24 hours
Intervention Type
Drug
Intervention Name(s)
erythropoietin Beta
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.2 ml saline solution X 3 given every 24 hours with the first dose within 12 hours of delivery
Primary Outcome Measure Information:
Title
Survival without neurologic sequelae
Time Frame
at 24 months
Secondary Outcome Measure Information:
Title
Mortality rates
Description
number of dead patients
Time Frame
Within 24 months
Title
Rate of moderate and severe sequelae
Description
Mental Developmental index (Brunet Lezine Test), motor, visual and hearing impairment
Time Frame
at 24 months
Title
Aspect of brain lesions on MRI
Description
Brain MRI performed between day 6 and day 12 after birth
Time Frame
at day 6 and day 12 after birth
Title
Tolerance of treatment
Time Frame
at 24 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana Patkai, MD, PhD
Organizational Affiliation
Cochin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
19651565
Citation
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.
Results Reference
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PubMed Identifier
25008465
Citation
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.
Results Reference
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Efficacy of Erythropoietin to Improve Survival and Neurological Outcome in Hypoxic Ischemic Encephalopathy

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