drugset / Trial / NCT00649961
Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study
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
Publications
- Background Jan JE, Wasdell MB, Freeman RD, Bax M. Evidence supporting the use of melatonin in short gestation infants. J Pineal Res. 2007 Jan;42(1):22-7. doi: 10.1111/j.1600-079X.2006.00398.x.
- Background Volpe JJ. Cerebral white matter injury of the premature infant-more common than you think. Pediatrics. 2003 Jul;112(1 Pt 1):176-80. doi: 10.1542/peds.112.1.176. No abstract available.
- Background Wood NS, Marlow N, Costeloe K, Gibson AT, Wilkinson AR. Neurologic and developmental disability after extremely preterm birth. EPICure Study Group. N Engl J Med. 2000 Aug 10;343(6):378-84. doi: 10.1056/NEJM200008103430601.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melatonin | Small molecule | 0.1 ug/kg | Intravenous |
| Subject | Melatonin | Small molecule | 0.5 ug/kg | Intravenous |