Clinical Trial: Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation
Brief Summary: The purpose of this study is to investigates serum and stool biomarkers as predictors for post-operative feeding intolerance in infant patients with complex congenital heart defects who undergo single ventricle staged palliation surgery.
Detailed Summary:
Sponsor: The University of Texas Health Science Center, Houston
Current Primary Outcome:
- Level of most abundant serum protein as determined by ELISA [ Time Frame: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery ]We will select two proteins with top changes that are involved in the pathways for intestinal inflammation, and levels will be determined with either ELISA or other techniques that are available.
- Level of second most abundant serum protein as determined by ELISA [ Time Frame: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery ]
- Level of stool biomarker interleukin-8 (IL-8) as determined by ELISA [ Time Frame: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery ]
- Level of stool biomarker calprotectin as determined by ELISA [ Time Frame: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: The University of Texas Health Science Center, Houston
Dates:
Date Received: December 13, 2016
Date Started: December 2016
Date Completion:
Last Updated: December 13, 2016
Last Verified: December 2016
