Erythropoietin in the treatment of birth asphyxia birth asphyxia.

A randomized double blind controlled trial of erythropoietin for neonatal hypoxic ischemic encephalopathy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/02/007918

Enrollment

192

Registered

2017-02-20

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- neonates with perinatal asphyxia

Interventions

Intervention1: Erythropoeitin: Following a standardized criteria, babies with HIE will be recruited and randomized either to receive erythropoietin or saline placebo. All other treatment modality is

Eligibility

Inclusion criteria

Inclusion criteria: 1.GA >35 wks and Birth weight > 1800 g 2.PHYSIOLOGICAL CRITERIA- Any 1 of the following a. ABG (Umbilical Cord/1st postnatal hr) pH - 12 b. Apgar score c. Ventilation required for at least 10â??as part of resuscitation d. History of not having cried at birth 3.NEUROLOGICAL CRITERIA- Seizures OR Evidence of moderate or severe encephalopathy (3 of 6 criteria in modified Sarnat)

Exclusion criteria

Exclusion criteria: 1. Lack of consent 2. Major congenital malformations 3. Imminent death anticipated at the time of assessment for eligibility 4. PCV > 65% 5. Any thrombosis 6. Blood pressure > 97th Centile

Design outcomes

Primary

Measure	Time frame
Death or severe neurodevelopmental impairment at 24 months (any of the following): (i) DASII overall score 70; (ii) Neurological examination score 40 (iii) GMFCS levels III,IV,V; (iv) Impaired sensory/communication outcomes: blindness, deafness, impaired communication using functional definitions, ongoing seizure disorder Timepoint: 24 months	—

Secondary

Measure	Time frame
Short term): MRI abnormalities at 5Â±1 days of life. Standardized Neurological examination at 7 days Intermediate term (10-15 weeks): Presence of Fidgety Movements (FM) using the General Movement Assessment (GMA) and a normal classification by the Computer based Infants Movement Analysis (CIMA). Long term: mild neurodevelopmental impairment (DASII score 70-84; Neurological examination score 40-67; or GMFCS level II); and individual subscale scores and impairments as appropriate. Timepoint: 5 days, 10-15days	—

Measure

Time frame

Short term): MRI abnormalities at 5Â±1 days of life. Standardized Neurological examination at 7 days Intermediate term (10-15 weeks): Presence of Fidgety Movements (FM) using the General Movement Assessment (GMA) and a normal classification by the Computer based Infants Movement Analysis (CIMA). Long term: mild neurodevelopmental impairment (DASII score 70-84; Neurological examination score 40-67; or GMFCS level II); and individual subscale scores and impairments as appropriate. Timepoint: 5 days, 10-15days

—

Countries

India

Contacts

Public ContactDr Niranjan Thomas

Christian Medical College and Hospital, Vellore, Tamil Nadu

niranjan@cmcvellore.ac.in04162283311

Outcome results

None listed

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