Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial)

Launched by IMPERIAL COLLEGE LONDON · May 24, 2022

Keywords

ClinConnect Summary

The EMBRACE Trial is studying a treatment called Erythropoietin (Epo) for newborns who experience neonatal encephalopathy (NE), a serious condition caused by a lack of oxygen at birth. This trial aims to find out if Epo can help improve outcomes for babies in low and middle-income countries, where access to advanced treatments like cooling therapy is often limited. Epo has shown promise in earlier research for reducing the risk of death or disability in babies with NE when used alone, without cooling therapy.

To be eligible for this trial, babies must be born in a hospital at or after 36 weeks of pregnancy and weigh at least 1.8 kilograms. They should also show signs of needing help at birth, such as a low score on a quick health check (called the Apgar score) or other signs of distress. Parents should know that the trial is currently recruiting participants, and if their baby qualifies, they can expect to receive Epo and be monitored for safety and effectiveness over time. This study is important because it could provide vital information about a new treatment option for vulnerable newborns in regions where traditional therapies may not be accessible.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria (all of below should be met)
• • Inborn babies born at a gestational age greater than or equal to 36 weeks, with a birth weight \>=1.8 kg
• • At least one of the following: need for continued resuscitation at 5 minutes of age; 5-minute Apgar score \< 6; metabolic acidosis (pH \< 7.0; base deficit \> 16 mmol/L) in cord or blood gas within the first hour of birth.
• • Moderate or severe neonatal encephalopathy on modified Sarnat staging performed between 1 to 6 hours after birth.
• Exclusion Criteria:
• • Imminent death at the time of recruitment
• • Babies born at home or those admitted after 6 hours of birth.
• • Major life-threatening congenital malformations
• • Head circumference \<30 cm at birth
• • Babies undergoing induced hypothermia
• • Migrant family or parents unable/unlikely to come back for follow-up at 18 months
• • Sentinel event and encephalopathy occurred only after birth
• • Unable to consent in primary language of parent(s)