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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

Tracking Information
First Submitted Date December 13, 2016
First Posted Date December 16, 2016
Last Update Posted Date December 16, 2016
Study Start Date December 2016
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 13, 2016)
  • 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.
  • 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 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation
Official Title Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Single Ventricle Physiology
Intervention
  • Other: Feeding tolerant
  • Other: Feeding intolerant
  • Other: Necrotizing enterocolitis
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Other: Feeding intolerant
  • Necrotizing enterocolitis
    Any infant that is diagnosed (radiographically, by Bell's criteria) with and treated for NEC.
    Intervention: Other: Necrotizing enterocolitis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 13, 2016)
30
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 3 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02995577
Other Study ID Numbers HSC-MS-16-0968
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Supriya Nair, The University of Texas Health Science Center, Houston
Study Sponsor The University of Texas Health Science Center, Houston
Collaborators Not Provided
Investigators
Principal Investigator: Supriya Nair, MD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date December 2016