Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation

Study Overview
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Brief Summary
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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.

Official Title
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Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation

Conditions
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Single Ventricle Physiology

Intervention / Treatment
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* Other: Feeding tolerant
* Other: Feeding intolerant
* Other: Necrotizing enterocolitis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full term gestational period (37 weeks gestation or greater) minimum of 2.5kg or greater body weight diagnosis of single ventricle physiology, or complex congenital cyanotic heart disease requiring staged palliation surgery in the form of Norwood-type procedure, systemic-to-pulmonary artery shunt, or pulmonary artery banding. Exclusion Criteria: Have diseases affecting other organs, have major congenital anomalies such as Hirschsprung disease, imperforate anus, CHARGE syndrome, or VACTERL association.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Feeding tolerant<br>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<br> <br> |
| Feeding intolerant<br>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<br> <br> |
| Necrotizing enterocolitis<br>Any infant that is diagnosed (radiographically, by Bell's criteria) with and treated for NEC. | Other: Necrotizing enterocolitis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of most abundant serum protein as determined by ELISA | 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. | baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery | 
| Level of second most abundant serum protein as determined by ELISA |  | 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 |  | 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 |  | baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery |