NCT02995577|Unknown
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Sponsor study identifier
observational
30
1 country
1
Study Start
December 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
Not reported
Date not reportedThe 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2016
Date type not reportedThis date has not been verified as actual or estimated.
December 13, 2016
Actual (reported)December 16, 2016
Actual (reported)May 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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.
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.
Any infant that is diagnosed (radiographically, by Bell's criteria) with and treated for NEC.
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.
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Supriya Nair, MD
The University of Texas Health Science Center, Houston
First Submitted
December 13, 2016
First Posted
December 16, 2016
Study Start
December 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2018
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 16, 2016
Record last verified: 2016-12
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Source: ClinicalTrials.gov.
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