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

Efecto Modulador de la Administracion Del Acido Docosahexaenoico Sobre la Respuesta Inflamatoria, la evolución Clinica y el Estado Nutricional de Neonatos Sometidos a cirugía

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01049529

Acronym

DHA-IRCO

Enrollment

Registered

2010-01-14

Start date

2007-03-31

Completion date

2012-09-30

Last updated

2017-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Organ Dysfunction Syndrome, Severe Sepsis

Keywords

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

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

Interventions

DIETARY_SUPPLEMENTDocosahexaenoic acid

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

DIETARY_SUPPLEMENTPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 45 Days

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026