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

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ClinicalTrials.gov Identifier: NCT02995577
Recruitment Status : Unknown
Verified December 2016 by Supriya Nair, The University of Texas Health Science Center, Houston.
Recruitment status was:  Recruiting
First Posted : December 16, 2016
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
Supriya Nair, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment
Single Ventricle Physiology Other: Feeding tolerant Other: Feeding intolerant Other: Necrotizing enterocolitis

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation
Study Start Date : December 2016
Estimated Primary Completion Date : May 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: Feeding tolerant
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.
Other: Feeding intolerant
Necrotizing enterocolitis
Any infant that is diagnosed (radiographically, by Bell's criteria) with and treated for NEC.
Other: Necrotizing enterocolitis



Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
  3. 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 ]
  4. 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 ]


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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995577


Contacts
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Contact: Supriya Nair, MD 832-582-0683 Supriya.Nair@uth.tmc.edu
Contact: J. Marc Rhoads, MD (713) 500-5663 J.Marc.Rhoads@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Supriya Nair, MD    832-582-0683    Supriya.Nair@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Supriya Nair, MD The University of Texas Health Science Center, Houston

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Responsible Party: Supriya Nair, Pediatric GI Fellow, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02995577     History of Changes
Other Study ID Numbers: HSC-MS-16-0968
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
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Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities