NCT01050660 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Boyd GW
An investigation of the prolonged pressor response to renin in the nephrectomized rat. Clin Sci Mol Med Suppl. 1976 Dec;3:151s-153s.
Colomb V, Jobert-Giraud A, Lacaille F, Goulet O, Fournet JC, Ricour C
Role of lipid emulsions in cholestasis associated with long-term parenteral nutrition in children. JPEN J Parenter Enteral Nutr. 2000 Nov-Dec;24(6):345-50.
Lee EJ, Simmer K, Gibson RA
Essential fatty acid deficiency in parenterally fed preterm infants. J Paediatr Child Health. 1993 Feb;29(1):51-5.

Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates

Clinical trial NCT01050660 - References