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Status:

RECRUITING

Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial)

Lead Sponsor:

Imperial College London

Conditions:

Encephalopathy

Erythropoietin

Eligibility:

All Genders

1-6 years

Phase:

PHASE3

Brief Summary

One million babies die, and at least 2 million survive with lifelong disabilities following neonatal encephalopathy (NE) in low and middle-income countries (LMICs), every year. Cooling therapy in the ...

Detailed Description

The burden of neonatal encephalopathy is far higher in low and middle-income countries. Recently, the Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial (HELIX) study concluded co...

Eligibility Criteria

Inclusion

  • Inclusion Criteria (all of below should be met)
  • Inborn babies born at a gestational age greater than or equal to 36 weeks, with a birth weight \>=1.8 kg
  • At least one of the following: need for continued resuscitation at 5 minutes of age; 5-minute Apgar score \< 6; metabolic acidosis (pH \< 7.0; base deficit \> 16 mmol/L) in cord or blood gas within the first hour of birth.
  • Moderate or severe neonatal encephalopathy on modified Sarnat staging performed between 1 to 6 hours after birth.
  • Exclusion Criteria:
  • Imminent death at the time of recruitment
  • Babies born at home or those admitted after 6 hours of birth.
  • Major life-threatening congenital malformations
  • Head circumference \<30 cm at birth
  • Babies undergoing induced hypothermia
  • Migrant family or parents unable/unlikely to come back for follow-up at 18 months
  • Sentinel event and encephalopathy occurred only after birth
  • Unable to consent in primary language of parent(s)

Exclusion

    Key Trial Info

    Start Date :

    December 31 2022

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 1 2026

    Estimated Enrollment :

    504 Patients enrolled

    Trial Details

    Trial ID

    NCT05395195

    Start Date

    December 31 2022

    End Date

    December 1 2026

    Last Update

    March 19 2024

    Active Locations (10)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (10 locations)

    1

    Bangabandhu Sheikh Mujib Medical University

    Dhaka, Bangladesh, 1000

    2

    Dhaka Medical College

    Dhaka, Bangladesh

    3

    Aurangabad Medical College

    Aurangabad, India

    4

    Bangalore Medical College

    Bangalore, India