Condition: Encephalopathy · Erythropoietin · Newborn Asphyxia · Sponsor: Imperial College London
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 context of modern tertiary intensive care improves outcome after NE in high-income countries. However, the uptake and applicability of cooling therapy in LMICs is poor, due to the lack of intensive care and transport facilities to initiate and administer the treatment within the six-hours window after birth as well as the absence of safety and efficacy data on hypothermia for moderate or severe NE. Erythropoietin (Epo) is a promising neuroprotectant with both acute effects (anti-inflammatory, anti-excitotoxic, antioxidant, and antiapoptotic) and regenerative effects (neurogenesis, angiogenesis, and oligodendrogenesis),which are essential for the repair of injury and normal neurodevelopment when used as a mono therapy in pre-clinical models (i.e without adjunct hypothermia). The preclinical data on combined use of Eythropoeitin and hypothermia is less convincing as the mechanisms overlap. Thus, the HEAL (High dose erythropoietin for asphyxia and encephalopathy) trial, a large phase III clinical trial involving 500 babies with with encephalopathy reported that that Erythropoietin along with hypothermia is not beneficial. In contrast, the pooled data from 5 small randomized clinical trials (RCTs) (n=348 babies), suggests that Epo (without cooling therapy) reduce the risk of death…
This description comes directly from the study's public registry record.
Reema Garegrat, DM · 02033132473 · r.garegrat@imperial.ac.uk
Ismita Chhettri, PhD · 02033132473 · i.chhetri@imperial.ac.uk
Always discuss trial participation with your own doctor first.
| 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 |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT05395195