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Whole body hypothermia plus melatonin vs hypothermia plus placebo in asphyxiated newborns
2012-000184-24Phase 3
- Sponsor
- Antonio Jerez Calero
- Start
- Apr 2014
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 3, randomised, double-blind trial in hypoxic-ischemic encephalopathy (HIE) and asphyxia neonatorum comparing Whole body hypothermia + melatonin with Whole body hypothermia + placebo (2 arms). Primary endpoint: Neurodevelopmental outcomes.
02
Drugs
melatonin
03
Conditions
hypoxic-ischemic encephalopathy (HIE)asphyxia neonatorum
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