Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation
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|ClinicalTrials.gov Identifier: NCT02995577|
Recruitment Status : Unknown
Verified December 2016 by Supriya Nair, The University of Texas Health Science Center, Houston.
Recruitment status was: Recruiting
First Posted : December 16, 2016
Last Update Posted : December 16, 2016
|Condition or disease||Intervention/treatment|
|Single Ventricle Physiology||Other: Feeding tolerant Other: Feeding intolerant Other: Necrotizing enterocolitis|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Observational Model:||Case Control|
|Official Title:||Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||May 2018|
Patients that are able to reach 80-100% of full enteral feeds (whether fed by mouth or through a nasogastric tube) 7 days after the initiation of feeds. Patients will be excluded from this group if they are ever diagnosed with NEC at any time during this hospitalization.
Other: Feeding tolerant
Patients with GI symptoms (vomiting, abdominal distention, diarrhea, hematemesis, and/or hematochezia) that persist for 48 hours or longer while needing to be NPO, this patient is retrospectively categorized into the feeding intolerance group. Patients with feeding intolerance may also include infants that are made NPO, placed on bowel rest, and are started on antibiotics to rule out NEC, but are never diagnosed with NEC. Exclusion criteria include patients that are continued on antibiotics for greater than 48 hours due to diagnosed bacterial sepsis or diagnosed NEC, and those that have a positive blood, urine, or sputum culture.
Other: Feeding intolerant
Any infant that is diagnosed (radiographically, by Bell's criteria) with and treated for NEC.
Other: Necrotizing enterocolitis
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995577
|Contact: Supriya Nair, MD||832-582-0683||Supriya.Nair@uth.tmc.edu|
|Contact: J. Marc Rhoads, MD||(713) 500-5663||J.Marc.Rhoads@uth.tmc.edu|
|United States, Texas|
|The University of Texas Health Science Center at Houston||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Supriya Nair, MD 832-582-0683 Supriya.Nair@uth.tmc.edu|
|Principal Investigator:||Supriya Nair, MD||The University of Texas Health Science Center, Houston|