Status:
RECRUITING
Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial)
Lead Sponsor:
Imperial College London
Conditions:
Encephalopathy
Erythropoietin
Eligibility:
All Genders
1-6 years
Phase:
PHASE3
Brief Summary
One million babies die, and at least 2 million survive with lifelong disabilities following neonatal encephalopathy (NE) in low and middle-income countries (LMICs), every year. Cooling therapy in the ...
Detailed Description
The burden of neonatal encephalopathy is far higher in low and middle-income countries. Recently, the Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial (HELIX) study concluded co...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
December 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT05395195
Start Date
December 31 2022
End Date
December 1 2026
Last Update
March 19 2024
Active Locations (10)
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1
Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh, 1000
2
Dhaka Medical College
Dhaka, Bangladesh
3
Aurangabad Medical College
Aurangabad, India
4
Bangalore Medical College
Bangalore, India