Darbepoetin in Neonatal Encephalopathy Trial

NCT04432662 | Recruiting Phase 2 DMC

• 1 other identifier: 277361
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 9

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 2 arm randomised control trial and aims to examine the physiological effects of 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 150 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 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.

Conditions

Neonatal Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure (Mean (SD) of thalamic NAA level)

  Mean (SD) of thalamic NAA level in babies treated with Darbe when compared with untreated infants.

  Expected average 1 to 2 weeks after birth

Secondary Outcomes (1)

• Secondary outcome measure (accurate quantification of NAA level)

  24 months

Study Arms (2)

Darbepoetin Alpha

ACTIVE COMPARATOR

Administration of Darbepoetin Alpha (10 mcg/kg) IV x2 doses following cooling therapy.

Drug: Darbepoetin Alfa

Standard of care

NO INTERVENTION

Standard of care: Cooling only

Interventions

Darbepoetin Alfa DRUG

Administration of Darbepoetin Alpha (10 mcg/kg) IV x2 doses following cooling therapy.

Darbepoetin Alpha

Eligibility Criteria

• Age: 1 Hour - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All the following criteria should be met
• Babies aged \< 24 hours, gestation age \>36 weeks with a birthweight \>1.8kg.
• 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.
• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (9)

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

Related Publications (1)

• Lally PJ, Montaldo P, Oliveira V, Soe A, Swamy R, Bassett P, Mendoza J, Atreja G, Kariholu U, Pattnayak S, Sashikumar P, Harizaj H, Mitchell M, Ganesh V, Harigopal S, Dixon J, English P, Clarke P, Muthukumar P, Satodia P, Wayte S, Abernethy LJ, Yajamanyam K, Bainbridge A, Price D, Huertas A, Sharp DJ, Kalra V, Chawla S, Shankaran S, Thayyil S; MARBLE consortium. Magnetic resonance spectroscopy assessment of brain injury after moderate hypothermia in neonatal encephalopathy: a prospective multicentre cohort study. Lancet Neurol. 2019 Jan;18(1):35-45. doi: 10.1016/S1474-4422(18)30325-9. Epub 2018 Nov 15.

  PMID: 30447969 BACKGROUND

MeSH Terms

Interventions

Darbepoetin alfa

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Sudhin Thayyil, PhD

CONTACT

02033132488; s.thayyil@imperial.ac.uk

Ismita Chhetri, PhD

CONTACT

02033132488; i.chhetri@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: May 28, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 2 years after the trial is published
• Access Criteria: Quality of the meta-analysis and the credibility of the team

Locations

GB (9)