Erythropoietin and Darbepoetin in Neonatal Encephalopathy Trial

• Status: Not yet recruiting
• Trial end date: 2023-09-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thayyil, Sudhin
• Treatments: Darbepoetin alfa; Epoetin Alfa

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