Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia
- Conditions
- Hypoxic Ischemic Encephalopathy
- Registration Number
- NCT02621944
- Lead Sponsor
- University of Florida
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria:<br><br> - Eligible infants are >36 0/7th weeks gestation,<br><br> - pH (cord or neonatal) <7.0,<br><br> - base deficit >16 mEq/L,<br><br> - no available blood gas,<br><br> - a cord blood/first hour of life blood gas with pH > 7.0 and < 7.15,<br><br> - base deficit between 10 and 15.9 mEq/L,<br><br> - infants must have a history of an acute perinatal event,<br><br> - either a 10-minute Apgar < 5 or a continued need for ventilation,<br><br> - All infants must have signs of encephalopathy within 6 hours of age using the<br> modified Sarnat scoring system,<br><br> - neonates cooled within 6 hours of birth will be included in the study.<br><br>Exclusion Criteria:<br><br> - suspected inborn errors of metabolism (elevated ammonia) and hypoglycemia,<br><br> - clinical signs and symptoms consistent with meningitis detected upon sepsis<br> evaluation,<br><br> - a diagnosis of congenital abdominal surgical problems along with multiple congenital<br> anomalies and/or chromosomal abnormalities.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To identify the maximum tolerated dose of Melatonin;Bayley-III Index Scores (Cognitive, Language, and Motor) will be used for neurological outcome assessment;Peak Plasma Concentration (Cmax) of Melatonin 0.5 mg/kg.;Number of participants with treatment-related adverse events as assessed by MedDRA ??? This is something the PI/Team needs to agree on which one to use.;Peak Plasma Concentration (Cmax) of Melatonin 3 mg/kg.;Peak Plasma Concentration (Cmax) of Melatonin 5 mg/kg.
- Secondary Outcome Measures
Name Time Method Bayley-III Index Scores Subscales (Receptive and Expressive Language, Fine and Gross Motor) will be used for neurological outcome assessment;Evaluation of The Impact of Melatonin using Magnetic Resonance Image (MRI)