Erythropoietin in perinatal asphyxia
- Conditions
- Health Condition 1: P916- Hypoxic ischemic encephalopathy [HIE]
- Registration Number
- CTRI/2023/06/053547
- Lead Sponsor
- Sawai man singh medical college and attached hospitals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
For inborns
1) Age <= 24 h, gestation >= 36 weeks (based on reported last menstrual period or ultrasound)
2) Need for continued resuscitation at 5 min of age and/or 5-min Apgar score < 6
3) Evidence of moderate or severe encephalopathy at < 24 h of age on a structured clinical examination based on modified Sarnat staging
For outborns
1) Age <= 24 h, gestation >= 36 weeks (based on reported last menstrual period or ultrasound)
2) Lack of crying by 5 min of age
3) Evidence of moderate or severe encephalopathy at < 24 h of age on a structured clinical examination based on modified Sarnat staging
1) Neonates with congenital anomalies, chromosomal abnormalities, congenital infections, severe intrauterine growth retardation and inborn errors of metabolism
2) Imminent death of the newborn before enrolment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the mortality rates in neonates with moderate to severe HIE among neonates who receive erythropoietin and routine supportive care with those who receive only routine supportive careTimepoint: From NICU admission till discharge or death
- Secondary Outcome Measures
Name Time Method To evaluate adverse events of EPO administrationTimepoint: From NICU admission till discharge or death;To evaluate Hammersmith infant neurological examination (HINE) on follow up at 3-6 months of ageTimepoint: 3-6 months of age;To evaluate the severity of brain injury on the basis of a standard score on conventional magnetic resonance imagingTimepoint: At the time of hospital discharge and on follow up