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

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.

Study Overview

• Status: Unknown
• Conditions: Single Ventricle Physiology
• Intervention / Treatment: Other: Feeding tolerant; Other: Feeding intolerant; Other: Necrotizing enterocolitis

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Supriya Nair, MD; Phone Number: 832-582-0683; Email: Supriya.Nair@uth.tmc.edu
• Study Contact Backup: Name: J. Marc Rhoads, MD; Phone Number: (713) 500-5663; Email: J.Marc.Rhoads@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Supriya Nair, MD; Phone Number: 832-582-0683; Email: Supriya.Nair@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 3 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will be infants with complex congenital cyanotic heart disease requiring single ventricle staged palliation surgery at Children's Memorial Hermann Hospital (CMHH) at the Texas Medical Center. This will include neonates undergoing single ventricle staged palliation in the form of (a) Norwood-type procedure, (b) systemic-to-pulmonary artery shunt procedure, or (c) pulmonary artery banding.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Feeding tolerant
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.	Other: Feeding intolerant
Necrotizing enterocolitis; Any infant that is diagnosed (radiographically, by Bell's criteria) with and treated for NEC.	Other: Necrotizing enterocolitis

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Supriya Nair, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (ANTICIPATED): May 1, 2018

Study Registration Dates

• First Submitted: December 13, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (ESTIMATE): December 16, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 16, 2016
• Last Update Submitted That Met QC Criteria: December 13, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Univentricular Heart
• Other Study ID Numbers: HSC-MS-16-0968