Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT02995577

Conditions

Single Ventricle Physiology

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

Interventions

Feeding tolerant

Feeding intolerant

Necrotizing enterocolitis

Study Details

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.

Conditions

Single Ventricle Physiology

Study ID

NCT02995577

Start date

Dec, 2016

Status verified date

Dec, 2016

Primary completion date

May, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Necrotizing enterocolitis

Any infant that is diagnosed (radiographically, by Bell's criteria) with and treated for NEC.

Interventions

Feeding tolerant

Feeding intolerant

Necrotizing enterocolitis

Primary outcome measure

  • Level of most abundant serum protein as determined by ELISA [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery ]

Central Contacts and Locations

Central contacts

Supriya Nair, MD

832-582-0683Supriya.Nair@uth.tmc.edu

J. Marc Rhoads, MD

(713) 500-5663J.Marc.Rhoads@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Supriya Nair, MD

832-582-0683Supriya.Nair@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Dec 16, 2016

Last verified

Dec, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2016-12-16.