drugset / Trial / NCT00649961

Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study

NCT00649961

NaSingle-groupOpen-labelOther

Summary

Preterm babies are at risk of brain injury. Melatonin, a naturally occurring hormone, may reduce this risk. The unborn baby receives melatonin from the mother but following premature delivery there maybe a period of prolonged melatonin deficiency. This deficiency may be harmful because studies suggest that melatonin is important in protecting the brain and reducing the risk of brain injury after preterm birth. The purpose of this study is to find the ideal dose of melatonin to give to preterm babies. We intend to study a total of 24 babies less than 31 weeks gestation and who are less than 7 days old.

Timeline

Start
2010-05
Primary completion
2011-02
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule 0.1 ug/kg Intravenous
Subject Melatonin Small molecule 0.5 ug/kg Intravenous

Indications