sage of Erythropoietin in neonates with brain injury to promote brain development in low and middle income countries.
- Conditions
- Health Condition 1: P038- Newborn affected by other specified complications of labor and delivery
- Registration Number
- CTRI/2023/01/049075
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method