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Completed

NCT Number: NCT01049529

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

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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Key information

Age range

1 day–45 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social

Mexico City, 06720, Mexico

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: n-3 LC-PUFAs, omega 3 fatty acids, Long chain polyunsaturated fatty acids

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

Other names: Life's DHA

Primary outcomes

  1. 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.

    Time frame: During the hospital stay, two weeks in average

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Registry information

Official study 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

Acronym: DHA-IRCO

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Jan 14, 2010
Registry last updated
Jan 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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