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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2012-09-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Severe Sepsis Organ Dysfunction Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Placebo group

This group is receiving sunflower oil (the excipient for DHA)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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

DHA group

This group is receiving the docosahexaenoic acid (DHA) supplement

Group Type ACTIVE_COMPARATOR

Docosahexaenoic acid

Intervention Type 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

Interventions

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Docosahexaenoic 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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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n-3 LC-PUFAs omega 3 fatty acids Long chain polyunsaturated fatty acids Life's DHA

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

45 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No