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Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial)

RecruitingPhase 3Ages 1 Hour - 6 HoursAllImperial College London
NCT05395195 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 context of modern tertiary intensive care improves outcome after NE in high-income countries. However, the uptake and applicability of cooling therapy in LMICs is poor, due to the lack of intensive care and transport facilities to initiate and administer the treatment within the six-hours window after birth as well as the absence of safety and efficacy data on hypothermia for moderate or severe NE. Erythropoietin (Epo) is a promising neuroprotectant with both acute effects (anti-inflammatory, anti-excitotoxic, antioxidant, and antiapoptotic) and regenerative effects (neurogenesis, angiogenesis, and oligodendrogenesis),which are essential for the repair of injury and normal neurodevelopment

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📋 Eligibility rules (as published)
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)
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What it tests

  • Erythropoietin
  • Supportive neonatal intensive care
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Where

10 sites
Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh
Dhaka Medical College
Dhaka, Bangladesh
Aurangabad Medical College
Aurangabad, India
Bangalore Medical College
Bangalore, India
Indira Gandhi Institute of Child Health
Bangalore, India
Institute of Child Health, Madras Medical College
Chennai, India
Kasturba Gandhi Medical College
Chennai, India
Karnataka Institute of Medical Sciences
Hubli, India

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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