Single Ventricle Physiology
Conditions
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.
Interventions
OTHERFeeding tolerant
OTHERFeeding intolerant
OTHERNecrotizing enterocolitis
Sponsors
The University of Texas Health Science Center, Houston
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 3 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | — |
Countries
United States
Contacts
Primary ContactSupriya Nair, MD
Backup ContactJ. Marc Rhoads, MD
Outcome results
None listed