Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feeding tolerant | Other |
| ||
| Feeding intolerant |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Supriya Nair, MD | Contact | 832-582-0683 | Supriya.Nair@uth.tmc.edu | |
| J. Marc Rhoads, MD | Contact | (713) 500-5663 | J.Marc.Rhoads@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Supriya Nair, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
Not provided
|
| Necrotizing enterocolitis | Other |
|