Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia
Recruiting
Early Phase 1
Interventional Study
Hypoxic Ischemic Encephalopathy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- Up to 6 Hours
- Sex
- Any
- Trial phase
- Early Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 70 (estimated)
- Sponsor
- University of Florida · Other
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About This Trial
Hypoxic-Ischemic Encephalopathy (HIE) occurs in 20 per 1000 births. Only 47% of neonates treated with the state of the art therapy (induced systemic hypothermia) have normal outcomes. Therefore, other promising therapies that potentially work in synergy with hypothermia to improve neurologic outcomes need to be tested. One potential agent is melatonin. Melatonin is a naturally occurring substance …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Eligible infants are \>36 0/7th weeks gestation,
* pH (cord or neonatal) \<7.0,
* base deficit \>16 mEq/L,
* no available blood gas,
* a cord blood/first hour of life blood gas with pH \> 7.0 and \< 7.15,
* base deficit between 10 and 15.9 mEq/L,
* infants must have a history …
Contacts