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Erythropoietin and Darbepoetin in Neonatal Encephalopathy Trial (EDEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04432662
Recruitment Status : Not yet recruiting
First Posted : June 16, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Thayyil, Sudhin

Brief Summary:

Hypoxic Ischemic Encephalopathy is also known as 'birth asphyxia related brain injury' and happens when the brain does not receive enough oxygen or blood flow around the time of birth. Birth asphyxia related brain injury is the most common cause of death and neurodisability in term babies.

Cooling therapy has substantially improved the outcomes of babies with HIE. However, unacceptably high rate of adverse outcomes are still seen in cooled babies with HIE.

The EDEN trial is a 3 arm randomised control trial and aims to examine the physiological effects of erythropoietin (Epo) and Darbepoetin alfa (Darbe) therapy on proton magnetic resonance spectroscopy thalamic N-acetylaspartate (NAA) level in babies with neonatal encephalopathy undergoing cooling therapy.

A total of 220 babies with neonatal encephalopathy will be recruited from the participating sites in UK over a 24 month period. The babies will be randomly allocated to erythropoietin, darbepoetin or usual care. MR imaging and spectroscopy will be performed at 1 to 2 weeks of age to examine the brain injury. Neurodevelopmental outcomes will be assessed at 18 months of age.


Condition or disease Intervention/treatment Phase
Neonatal Encephalopathy Drug: Erythropoietin Drug: Darbepoetin Alfa Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Erythropoietin and Darbepoetin in Neonatal Encephalopathy (EDEN) Trial
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 2, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Erythropoietin
Administration of Erythropoietin (1000 U/kg) IV once a day x 5 doses along with cooling therapy
Drug: Erythropoietin
Administration of Erythropoietin (1000 U/kg) IV once a day x 5 doses along with cooling therapy

Active Comparator: Darbepoetin Alpha
Administration of Darbepoetin Alpha (10 mcg/kg) IV single dose given less than 24 hours of age along with cooling therapy
Drug: Darbepoetin Alfa
Administration of Darbepoetin Alpha (10 mcg/kg) IV single dose given less than 24 hours of age along with cooling therapy.

No Intervention: Standard of care
Standard of care: Cooling only



Primary Outcome Measures :
  1. Primary outcome measure (Mean (SD) of thalamic NAA level) [ Time Frame: Expected average 1 to 2 weeks after birth ]
    Mean (SD) of thalamic NAA level in babies treated with Epo and Darbe when compared with untreated infants.


Secondary Outcome Measures :
  1. Secondary outcome measure (accurate quantification of NAA level) [ Time Frame: 24 months ]
    Number of babies in whom thalamic NAA level could be accurately quantified in 3Telsa and 1.5Tesla MR scanners.



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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age < 24 hours
  2. Birth-weight >1.8 kg
  3. Gestation >=36 weeks
  4. Need for continued resuscitation at 10 minutes after birth and/or 10 minutes Apgar score <6
  5. Cooling therapy initiated for neonatal encephalopathy within 6 hours of age as a part of standard clinical care, with an intention of continuing for 72 hours.

Exclusion Criteria:

  1. Major life-threatening congenital malformation.
  2. Concomitant participation in other research projects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04432662


Contacts
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Contact: Sudhin Thayyil, PhD 02033132488 s.thayyil@imperial.ac.uk
Contact: Stuti Pant, MA 02033132488 s.pant@imperial.ac.uk

Locations
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United Kingdom
Birmingham Womens Hospital
Birmingham, United Kingdom
Contact: Manobi Boorah, FRCPCH         
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, United Kingdom
Contact: Sam Oddie       sam.oddie@bthft.nhs.uk   
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Contact: Topun Austin, MD         
Medway NHS Foundation Trust
Gillingham, United Kingdom
Contact: Dr Aung Soe, FRCPCH       aung.soe@medway.nhs.uk   
Contact: Russel Pryce, PhD         
Liverpool Womens NHS Foundation Trust
Liverpool, United Kingdom
Contact: Balamurugan Palanisami, MBBS       Balamurugan.Palanisami@lwh.nhs.uk   
Homerton University Hospital
London, United Kingdom
Contact: Narendra Aldangady         
Imperial College Healthcare Trust
London, United Kingdom
Contact: Gaurav Atreja, MD    02033131134    gatreja@nhs.net   
Contact: Maria Moreno Morales, BsC    02033132473    m.moreno-morales@imperial.ac.uk   
The Newcastle Upon Tyne NHS Foundation Trust
Newcastle, United Kingdom
Contact: Dr Sundeep Harigopal       sundeep.harigopal@nuth.nhs.uk   
Sponsors and Collaborators
Thayyil, Sudhin
Publications:
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Responsible Party: Thayyil, Sudhin
ClinicalTrials.gov Identifier: NCT04432662    
Other Study ID Numbers: 277361
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD data will be shared for meta-analysis
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: 2 years after the trial is published
Access Criteria: Quality of the meta-analysis and the credibility of the team

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epoetin Alfa
Darbepoetin alfa
Hematinics