Status:
COMPLETED
Inflammatory Responses to Lipid Emulsions in Children Before and After Open Heart Surgery
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Stollery Children's Hospital Foundation
Conditions:
Inflammation
Cardiac Surgical Procedures
Eligibility:
All Genders
Up to 3 years
Phase:
PHASE2
PHASE3
Brief Summary
This study is a blinded, randomized, controlled prospective trial comparing immune response (sepsis, inflammatory response, pulmonary vasoconstriction) in 2 groups of infants less than 3-month old rec...
Eligibility Criteria
Inclusion
- 36 weeks gestation
- 3 months corrected age
- appropriate for gestational age (AGA)
- admitted for surgical correction of congenital heart defects (single ventricle, tetralogy of Fallot, truncus and complex biventricular repairs)
- enteral nutrition at 30 kcal/kilogram/day
Exclusion
- 5 minute Apgar score of 4
- major congenital defect other than heart defect
- presence of significant neonatal morbidity (intraventricular hemorrhage (IVH) grade 3 or greater, necrotizing enterocolitis (NEC) and surgical abdomen)
- any metabolic disorder
- any endocrine disorder
- medications which alter eicosanoid metabolism including indomethacin, acetylsalicylate (with exception of steroids which will be analyzed independently)
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00336908
Start Date
November 1 2005
End Date
November 1 2007
Last Update
November 27 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7