Erythropoietin for Perinatal asphyxia

Use of Recombinant human Erythropoietin as Neuroprotective agent in Hypoxic Ischemic Encephalopathy in term newborns- An open label, randomized controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/04/013331

Enrollment

200

Registered

2018-04-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Admitted to NICU for perinatal asphyxia

Interventions

Intervention1: Inj human recombinant erythropoeitin: Inj rhEPO 500 IU/kg IV diluted in 2 ml NS on alternate days for 5 doses Control Intervention1: Placebo: Inj Normal saline will be used as Placebo

Eligibility

Inclusion criteria

Inclusion criteria: Term newborns with Moderate to severe hypoxic ischemic encephalopathy in babies with history of fetal distress like APGAR score <5 at 5 min, ongoing resuscitation or mechanical ventilation at 10 min

Exclusion criteria

Exclusion criteria: Major congenital anomalies, Preterm babies ( <37 wks GA), No spontaneous respiration at 30 min of life, Outborn babies, Parental refusal to consent

Design outcomes

Primary

Measure	Time frame
1.Neonatal Mortality 2.Moderate to severe neurodevelopmental disability at 6 month of ageTimepoint: at 6 month of age	—

Secondary

Measure	Time frame
1.Seizure frequency 2.Need of ventilation 3.Neuroimaging abnormalities at discharge and 6 month of lifeTimepoint: at discharge and 6 month of age	—

Countries

India

Contacts

Public ContactDr Atul Londhe

GOVT MEDICAL COLLEGE AURANGABAD

atul.londhe1982@gmail.com8275453997

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026