Erythropoietin treatment for newborns with encephalopathy in low and middle-income countries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the use of Erythropoietin, a neuroprotective agent, as a treatment for neonatal encephalopathy in newborns from low and middle-income countries. The study aims to assess the efficacy of Erythropoietin in improving outcomes for infants who exhibit signs of moderate to severe encephalopathy shortly after birth. Participants will receive Erythropoietin along with supportive neonatal intensive care, and their progress will be monitored over 18 months. The trial addresses the limitations of existing cooling therapies that have not proven effective in these settings.

Why it matters

Who can join: the full rules

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)

Where it's running

• Bangabandhu Sheikh Mujib Medical University
  Dhaka, Bangladesh Recruiting
• Bangalore Medical College
  Bangalore, India Recruiting
• Indira Gandhi Institute of Child Health
  Bangalore, India Recruiting
• Institute of Child Health, Madras Medical College
  Chennai, India Recruiting
• Kasturba Gandhi Medical College
  Chennai, India Recruiting
• Aurangabad Medical College
  Chhatrapati Sambhajinagar, India Recruiting

Study contacts

• Principal investigator: Sudhin Thayyil, PhD — Imperial College London
• Study coordinator: Reema Garegrat, DM
• Email: r.garegrat@imperial.ac.uk
• Phone: 02033132473

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.