NCT02929303 - 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)

Sant'Anna AM, Altamimi E, Clause RF, Saab J, Mileski H, Cameron B, Fitzgerald P, Sant'Anna GM
Implementation of a multidisciplinary team approach and fish oil emulsion administration in the management of infants with short bowel syndrome and parenteral n
Soden JS, Lovell MA, Brown K, Partrick DA, Sokol RJ
Failure of resolution of portal fibrosis during omega-3 fatty acid lipid emulsion therapy in two patients with irreversible intestinal failure. J Pediatr. 2010 Feb;156(2):327-31. doi: 10.1016/j.jpeds.20

Expanded Access of Omegaven IV Fat Emulsion (Fish Oil Infusion) to Infants and Children With Parenteral Nutrition-associated Liver Disease

Clinical trial NCT02929303 - References