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

The University of Texas System (UT)

Status: Unknown

Conditions: Single Ventricle Physiology

Treatments: Other: Feeding tolerant; Other: Necrotizing enterocolitis; Other: Feeding intolerant

Study type: Observational

Funder types: Other

Identifiers

NCT02995577

HSC-MS-16-0968

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 1 day to 3 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 3 patient groups

Feeding tolerant

Description:

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.

Treatment:

Other: Feeding tolerant

Feeding intolerant

Description:

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.

Treatment:

Other: Feeding intolerant

Necrotizing enterocolitis

Description:

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

Treatment:

Other: Necrotizing enterocolitis