Erythropoietin Monotherapy in Neonatal Encephalopathy in Low and Middle-Income Countries(EMBRACE) - EMBRACE

Imperial College London0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年2月6日

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•All inborn babies born at a gestational age > 36 weeks, with a birth weight >2kg will be screened for eligibility and recruited if they meet the inclusion criteria.
•Inclusion criteria (Both A and B required)
•A.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.
•B.Moderate or severe neonatal encephalopathy on modified Sarnat staging performed between 1 to 3 hours after birth.

•(i)Imminent death at the time of recruitment
•(ii)Babies born at home or another hospital (Out born babies)
•(iii)Major congenital malformations
•(iv)Head circumference <30 cm at birth
•(v)Polycythaemia with a venous haematocrit >65% at the time of recruitment
•(vi)Babies undergoing therapeutic hypothermia
•(vii)Migrant family or parents unable/unlikely to come back for follow-up at 18 months
•(viii)Sentinel event and encephalopathy occurred only after birth
•(ix)Unable to consent in primary language of parent(s)

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