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

• Conditions: Single Ventricle Physiology
• Interventions: Other: Feeding tolerant; Other: Necrotizing enterocolitis; Other: Feeding intolerant

• Registration Number: NCT02995577
• Lead Sponsor: The University of Texas Health Science Center, Houston

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 Description

Not available

Study Timeline

• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-13
• Last Update Submitted: 2016-12-13
• Study First Posted: 2016-12-16
• Last Update Posted: 2016-12-16
• Primary Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Feeding tolerant	Feeding tolerant	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.
Necrotizing enterocolitis	Necrotizing enterocolitis	Any infant that is diagnosed (radiographically, by Bell's criteria) with and treated for NEC.
Feeding intolerant	Feeding intolerant	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.

Primary Outcome Measures

Name	Time	Method
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 most abundant serum protein as determined by ELISA	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 stool biomarker calprotectin as determined by ELISA	baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States