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

Single Ventricle Physiology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02995577
• Other study ID #: HSC-MS-16-0968
• Status: Recruiting
• Phase: N/A
• First received: December 13, 2016
• Last updated: December 13, 2016
• Start date: December 2016

Study information

• Verified date: December 2016
• Source: The University of Texas Health Science Center, Houston
• Contact: Supriya Nair, MD
• Phone: 832-582-0683
• Email: Supriya.Nair[@]uth.tmc.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Defects, Congenital
• Single Ventricle Physiology

Intervention

Other:
• Feeding tolerant

• Feeding intolerant

• Necrotizing enterocolitis

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes