Darbepoetin in Neonatal Encephalopathy Trial

Launched by IMPERIAL COLLEGE LONDON · Jun 15, 2020

Keywords

ClinConnect Summary

The Darbepoetin in Neonatal Encephalopathy Trial is a study designed to explore the effects of a medication called Darbepoetin alfa on babies who experience a serious condition known as neonatal encephalopathy, which can occur when a baby does not get enough oxygen during birth. This trial aims to improve outcomes for these babies, especially since cooling therapy has helped but still leaves some babies with challenges. The trial will involve 150 babies who are less than 24 hours old and meet specific health criteria, such as having a certain birth weight and showing signs of brain injury at birth.

Eligible babies will be randomly assigned to receive either Darbepoetin or standard care during their hospital stay. Researchers will use special brain imaging techniques to assess brain injury when the babies are about 1 to 2 weeks old and will follow up on their development when they reach 18 months. If you have a baby who may qualify for this study, it's important to know that participation could help advance medical knowledge and improve future care for babies with similar conditions.

Gender

ALL

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