NCT01745510 - 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)

Bernabe-García M, Calder PC, Villegas-Silva R, Rodríguez-Cruz M, Chávez-Sánchez L, Cruz-Reynoso L, Mateos-Sánchez L, Lara-Flores G, Aguilera-Joaquín AR, Sánchez-García L
Efficacy of Docosahexaenoic Acid for the Prevention of Necrotizing Enterocolitis in
Bernabe-Garcia M, Lopez-Alarcon M, Villegas-Silva R, Mancilla-Ramirez J, Rodriguez-Cruz M, Maldonado-Hernandez J, Chavez-Rueda KA, Blanco-Favela F, Espinoza-Garcia L, Lagunes-Salazar S
Beneficial Effects of Enteral Docosahexaenoic Acid on the Markers of Inflammation and Clinical Outcomes of Neonates Undergoing Cardiovascular Surgery: An Intervention Study. Ann Nutr Metab. 2016;69(1):15-23. doi: 10.1159/000447498. Epub 2016 Jul 9.
López-Alarcón M, Bernabe-García M, Del Prado M, Rivera D, Ruiz G, Maldonado J, Villegas R
Docosahexaenoic acid administered in the acute phase protects the nutritional status of septic neonates. Nutrition. 2006 Jul-Aug;22(7-8):731-7. Epub 2006 Jun 5.
López-Alarcón M, Bernabe-García M, del Valle O, González-Moreno G, Martínez-Basilea A, Villegas R
Oral administration of docosahexaenoic acid attenuates interleukin-1ß response and clinical course of septic neonates. Nutrition. 2012 Apr;28(4):384-90. doi: 10.1016/j.nut.2011.07.016. Epub 2011 Nov 12.

Efficacy of Enteral Administration of the Docosahexaenoic Acid on Necrotizing Enterocolitis, Cytokines and Hospital Stay in Preterm Neonates

Clinical trial NCT01745510 - References