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| ID | Type | Description | Link |
|---|---|---|---|
| 2005/1/I/193 | Other Grant/Funding Number | Fondo para la Investigación en Salud, IMSS |
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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
Severe sepsis and organ failure are leading causes of death in surgical patients. Several studies indicate that a causal relationship exists between the surgical or traumatic injury and the predisposition to develop septic/infectious complications and multiple organ failure; this is attributable to uncontrolled inflammatory response. Since neonates have an immature immune system, they are in a higher risk to develop uncontrolled inflammatory response and adverse clinical outcomes.
N-3 long chain polyunsaturated fatty acids (L-PUFAs) such as docosapentaenoic and docosahexaenoic acids (EPA and DHA) have been shown to reduce the inflammatory response by reducing cytokines, infection rates and length of hospitalization in patients with abdominal surgery. Therefore, acute and enteral administration of DHA may improve clinical outcomes in neonates with cardiovascular surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | This group is receiving sunflower oil (the excipient for DHA) |
|
| DHA group | Active Comparator | This group is receiving the docosahexaenoic acid (DHA) supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docosahexaenoic acid | Dietary Supplement | DHA have oil form. Each neonate is receiving 75 mg/kg/day of DHA in 188 uL/kg/day in two doses per day, since two days before surgery and over six days following cardiovascular surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariela Bernabe-Garcia, PhD | Instituto Mexicano del Seguro Social | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social | Mexico City | Mexico City | 06720 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16750345 | Background | Lopez-Alarcon M, Bernabe-Garcia 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. doi: 10.1016/j.nut.2006.04.002. Epub 2006 Jun 5. | |
| 22079797 | Background | Lopez-Alarcon M, Bernabe-Garcia M, del Valle O, Gonzalez-Moreno G, Martinez-Basilea A, Villegas R. Oral administration of docosahexaenoic acid attenuates interleukin-1beta 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. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Placebo | Dietary Supplement | Placebo have oil form. Each neonate is receiving 188uL/kg/day of sunflower oil as placebo in two doses per day, since two days before surgery and over six days following cardiovascular surgery |
|
|
| 27394149 | Result | 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. |
| 27806350 | Result | Bernabe-Garcia M, Lopez-Alarcon M, Salgado-Sosa A, Villegas-Silva R, Maldonado-Hernandez J, Rodriguez-Cruz M, Rivas-Ruiz R, Chavez-Sanchez L, Blanco-Favela FA, Mancilla-Ramirez J, Gordillo-Alvarez V, Madrigal-Muniz O. Enteral Docosahexaenoic Acid Reduces Analgesic Administration in Neonates Undergoing Cardiovascular Surgery. Ann Nutr Metab. 2016;69(2):150-160. doi: 10.1159/000452227. Epub 2016 Nov 2. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |