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

Erythropoietin Monotherapy for Brain Regeneration in Neonatal Encephalopathy in Low and Middle-Income Countries

This study is testing whether Erythropoietin can help improve the health of newborns with brain issues shortly after birth in low and middle-income countries.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 504 (estimated)
• Ages: 1 Hour to 6 Hours
• Sex: All
• Sponsor: Imperial College London (Academic / other)
• Locations: 10 sites (Dhaka and 9 other locations)
• Trial ID: NCT05395195 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include inborn babies born at or after 36 weeks of gestation, weighing at least 1.8 kg, and showing signs of moderate to severe neonatal encephalopathy shortly after birth.

Not a fit: Patients who are imminently dying, have major congenital malformations, or were born at home may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce mortality and long-term disabilities in newborns suffering from encephalopathy.

How similar studies have performed: Previous studies have shown that Erythropoietin has neuroprotective effects in preclinical models, but this specific approach in the context of neonatal encephalopathy in LMICs is novel.

Eligibility criteria

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 this trial is running

Dhaka and 9 other locations

• Bangabandhu Sheikh Mujib Medical University — Dhaka, Bangladesh (Recruiting)
• Dhaka Medical College — Dhaka, Bangladesh (Not_yet_recruiting)
• Aurangabad Medical College — Aurangabad, India (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)
• Karnataka Institute of Medical Sciences — Hubli, India (Recruiting)
• Lokmanya Tilak Municipal Medical College — Mumbai, India (Recruiting)
• University of Kelaniya — Kelaniya, Sri Lanka (Not_yet_recruiting)

Study contacts

• Principal investigator: Sudhin Thayyil, PhD — Imperial College London
• Study coordinator: Reema Garegrat, DM

Conditions Encephalopathy; Erythropoietin; Newborn Asphyxia