Health Condition 1: P916- Hypoxic ischemic encephalopathy [HIE]
Conditions
Interventions
Intervention1: intravenous erythropoeitin: i.v erythropoeitin 1000 IU/kg on alternate days for initial 10 days of life
Control Intervention1: Standard routine care: Neonate will receive the same stand
Sponsors
Sawai man singh medical college and attached hospitals
Eligibility
Inclusion criteria
Inclusion criteria: For inborns 1) Age = 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 3) Evidence of moderate or severe encephalopathy at For outborns 1) Age = 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Ramesh Choudhary
Sawai Man Singh Medical College and attached hospitals Jaipur
Outcome results
None listed