Darbepoetin treatment for babies with brain injury from birth asphyxia

Darbepoetin in Neonatal Encephalopathy (EDEN) Trial

This study is testing if a treatment called Darbepoetin can help improve brain health in newborns who have suffered brain injuries from lack of oxygen at birth.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 1 Hour to 24 Hours
• Sex: All
• Sponsor: Imperial College London (Academic / other)
• Locations: 9 sites (Birmingham and 8 other locations)
• Trial ID: NCT04432662 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of Darbepoetin alfa therapy on brain health in newborns suffering from neonatal encephalopathy due to hypoxic ischemic events. It is a randomized control trial involving 150 infants who will receive either Darbepoetin or standard care while undergoing cooling therapy. The study will assess changes in brain metabolites using proton magnetic resonance spectroscopy, focusing on thalamic N-acetylaspartate levels. The trial aims to improve outcomes for infants who experience birth asphyxia-related brain injuries.

Who should consider this trial

Good fit: Ideal candidates are newborns under 24 hours old, with a gestational age over 36 weeks and evidence of acute perinatal asphyxia.

Not a fit: Patients with major life-threatening congenital malformations will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the rates of adverse neurological outcomes in infants affected by neonatal encephalopathy.

How similar studies have performed: Other studies have shown promise in using similar therapeutic approaches, but this specific application of Darbepoetin in neonatal encephalopathy is novel.

Eligibility criteria

Inclusion Criteria:

All the following criteria should be met

1. Babies aged \< 24 hours, gestation age \>36 weeks with a birthweight \>1.8kg.
2. Acute perinatal asphyxia (metabolic acidosis in cord and/or blood gas (pH\<7.0; base deficit \> 16 mmol/L) within first 1 hour of birth). If pH between 7.01 and 7.15, a base deficit between 10 and 15.9 mmol/L, additionally acute obstetric event and either need for continued resuscitation or ventilation at 10 minutes after birth and/or 10 minutes Apgar score \<5 is required.
3. Evidence of mild, moderate, or severe encephalopathy on an NICHD neurological examination performed between 1 and 6 hours of birth. The worst recorded encephalopathy stage between 1 and 6 hours of birth should be used.
4. 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

Where this trial is running

Birmingham and 8 other locations

• Birmingham Womens Hospital — Birmingham, United Kingdom (Not_yet_recruiting)
• Bradford Teaching Hospitals NHS Foundation Trust — Bradford, United Kingdom (Not_yet_recruiting)
• Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom (Not_yet_recruiting)
• Medway NHS Foundation Trust — Gillingham, United Kingdom (Recruiting)
• Liverpool Womens NHS Foundation Trust — Liverpool, United Kingdom (Not_yet_recruiting)
• Homerton University Hospital — London, United Kingdom (Recruiting)
• Imperial College Healthcare Trust — London, United Kingdom (Recruiting)
• Bedfordshire Hospitals NHS Foundation Trust — Luton, United Kingdom (Recruiting)
• The Newcastle Upon Tyne NHS Foundation Trust — Newcastle, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Sudhin Thayyil, PhD

Conditions Neonatal Encephalopathy