Effect of Docosahexaenoic Acid on the Inflammatory Response and Clinical Outcomes From Surgical Patients

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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

Official 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

Conditions
-----------------
Severe Sepsis, Organ Dysfunction Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Docosahexaenoic acid
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 45 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>This group is receiving sunflower oil (the excipient for DHA) | Dietary Supplement: Placebo<br>* 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<br>* Other names: Life's DHA;|
| Active Comparator: DHA group<br>This group is receiving the docosahexaenoic acid (DHA) supplement | Dietary Supplement: Docosahexaenoic acid<br>* 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<br>* Other names: Long chain polyunsaturated fatty acids;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Docosahexaenoic acid, n-3 Long Chain Polyunsaturated Fatty Acids, omega 3 fatty acids, neonates, clinical outcomes, critically ill patients, Inflammatory and antiinflammatory cytokines, Length of intensive care stay