Creation of specimen biorepository and analysis of transcriptome and metabolome as potential mechanism in intestinal failure associated liver disease in neonate

K
Katie Huff

Primary Investigator

Enrolling By Invitation
100 years and younger
All
Phase N/A
100 participants needed
2 Locations

Brief description of study

We will build a biorepository of blood and urine samples correlated with clinical data in neonates receiving parenteral nutrition in order to study IFALD

Detailed description of study

The goal of this study is to form a biobank of blood and urine specimens from infants who require prolonged IV nutrition and either are at high risk or already have liver complications. Patients will be enrolled at part of one of two groups: GROUP A (Early, no liver irritation) or GROUP B (late, liver irritation). All patients will have samples collected at set timepoints dependent on the course with regards to need for IV nutrition need and development or resolution of liver irritation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: biobank, Riley
  • Age: - 100 Years
  • Gender: All

Inclusion Criteria:
  • 1.     Inability to initiate enteral feeding
    2.     Diagnosis at high risk for PN dependence:
    a.     Gastroschisis
    b.     Small bowel atresia
    c.      Volvulus
    d.     Necrotizing enterocolitis requiring surgical intervention
    e.     Intestinal perforation
    3.     Surgical procedure increasing risk of PN dependence:
    a.     Small bowel resection
    b.     Duodenostomy
    c.      Jejunostomy
    d.     Diagnosis of short bowel syndrome
Exclusion Criteria:
  • 1.     PN treatment for more than 3 days (72 hours) within 2 weeks prior to baseline specimen collection
    2.     Direct bilirubin >2 mg/dL at baseline
    3.     AST or ALT more than twice upper limit of normal
    4.     Known or suspected congenital infection including HSV, CMV, toxoplasmosis
    5.     Primary liver disease
    6.     Inborn error of metabolism
    7.     Sepsis defined as positive blood, urine, or CSF cultures within 2 weeks of enrollment

Updated on 13 Sep 2024. Study ID: 12740, PNEO-IIR-IFALD
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