Severe Sepsis Clinical Trial
— DHA-IRCOOfficial title:
Efecto Modulador de la Administracion Del Acido Docosahexaenoico Sobre la Respuesta Inflamatoria, la evolución Clinica y el Estado Nutricional de Neonatos Sometidos a cirugía
Verified date | January 2017 |
Source | Coordinación de Investigación en Salud, Mexico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate if enteral docosahexaenoic acid (DHA) administration attenuates the inflammatory cytokines and improve clinical outcomes in neonates who underwent cardiovascular surgery
Status | Completed |
Enrollment | 55 |
Est. completion date | September 2012 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 45 Days |
Eligibility |
Inclusion Criteria: - Authorization from both parents for recruiting of the neonate into the study with consent signed form after the purpose and procedures have been explained - Gestational age older than 32 weeks - Adequate weight for gestational age - Gastrointestinal tract that allows tolerate the doses of DHA or placebo - No signs of Systemic Inflammatory Response Syndrome before the surgery as fever >38 degrees C or hypothermia <36 degrees C, or leukocytosis >19,500 cells/cubic mm or < 5000 cells/cubic mm or > 10% immature forms. Exclusion Criteria: - Fasting for more than two days after surgery - Discharge to other hospital outside the metropolitan area - Parents who decide to decline of the study - Patients who necessitate cardiovascular bypass |
Country | Name | City | State |
---|---|---|---|
Mexico | Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social | Mexico | Distrito Federal |
Lead Sponsor | Collaborator |
---|---|
Coordinación de Investigación en Salud, Mexico |
Mexico,
Bernabe-Garcia M, López-Alarcon M, Salgado-Sosa A, Villegas-Silva R, Maldonado-Hernandez J, Rodríguez-Cruz M, Rivas-Ruiz R, Chavez-Sanchez L, Blanco-Favela FA, Mancilla-Ramirez J, Gordillo-Alvarez V, Madrigal-Muñiz O. Enteral Docosahexaenoic Acid Reduces — View Citation
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 — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Inflammatory response measured by cytokines IL-1, IL-6, TNF-alfa, IL-10 e IL-1ra and clinical outcomes assessed as frequency of severe sepsis, respiratory and cardiovascular dysfunction. | During the hospital stay, two weeks in average |
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