70
Participants
Start Date
November 30, 2016
Primary Completion Date
March 31, 2026
Study Completion Date
March 31, 2026
Melatonin
Participants 1-10 will receive a 0.5 mg/kg enteral dose of Melatonin. Participants 11-20 will receive Melatonin dose of 3 mg/kg enteral. Participants 21-30 will receive Melatonin dose of 5 mg/kg enterally.
Magnetic Resonance Imaging
All participants will receive an MRI between 7-12 days of age.
Pharmacokinetics
All participants will receive pharmacokinetics to test the amount of melatonin in the blood.
Neurological Outcome Assessment
All participants will receive the Bayley-III Scores and Subsets for neurological outcome assessments.
RECRUITING
University of Florida, Gainesville
RECRUITING
Florida Hospital for Children, Orlando
Thrasher Research Fund
OTHER
University of Florida
OTHER