Usage of Erythropoietin in neonates with brain injury to promote brain development in low and middle income countries.

Erythropoietin Monotherapy in Neonatal Encephalopathy in Low and Middle-Income Countries(EMBRACE) - EMBRACE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/049075

Enrollment

504

Registered

2023-01-18

Start date

Unknown

Completion date

Unknown

Last updated

2023-02-06

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

Conditions

Health Condition 1: P038- Newborn affected by other specified complications of labor and delivery

Interventions

Intervention1: Erythropoietin: Sub cutaneous injections of Eythropoeitin x 9 doses (500 U/kg per dose) till 8 days Control Intervention1: Dummy injection: Empty syringes without needle

Eligibility

Inclusion criteria

Inclusion criteria: 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 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.

Exclusion criteria

Exclusion criteria: (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 (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)

Design outcomes

Primary

Measure	Time frame
Death or moderate or severe disability at 18 months of age. â?¢Moderate disability will be defined as a Bayley IV cognitive composite score of 70â??84 and one or more of the following: Gross Motor Function Classification System level II; hearing impairment requiring amplification to understand commands; or epilepsy. â?¢Severe disability will be defined as any one of the following: Bayley IV cognitive composite score 70; Gross Motor Function Classification System level 3â??5; inability to hear/understand commands despite amplification with hearing aids; or blindness. Timepoint: 18 to 22 months	—

Measure

Time frame

Death or moderate or severe disability at 18 months of age. â?¢Moderate disability will be defined as a Bayley IV cognitive composite score of 70â??84 and one or more of the following: Gross Motor Function Classification System level II; hearing impairment requiring amplification to understand commands; or epilepsy. â?¢Severe disability will be defined as any one of the following: Bayley IV cognitive composite score 70; Gross Motor Function Classification System level 3â??5; inability to hear/understand commands despite amplification with hearing aids; or blindness. Timepoint: 18 to 22 months

—

Secondary

Measure	Time frame
Cerebral palsyTimepoint: 18 to 22 months;DeathTimepoint: 22 months;MicrocephalyTimepoint: 18-22 months;Severe disabilityTimepoint: 18 to 22 months;Survival without neurodisabilityTimepoint: 18-22 months	—

Countries

Bangladesh, India, Sri Lanka

Contacts

Public ContactSutapa Neogi

International Institute of Health Management Research

sutapa@iihmrdelhi.edu.in011-30418901

Outcome results

None listed

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