Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:4/17/2018
Start Date:February 2012
End Date:December 31, 2018
Contact:Sanjiv Amin, MD, MS
Email:sanjiv_amin@urmc.rochester.edu
Phone:5852732696

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Trial Summary
Trial Overview
Inclusion Criteria

Effect of Lipid Intake on Direct Hyperbilirubinemia in Late Preterm and Term Infants With Gastrointestinal Surgical Problems.

The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in
late preterm and term neonates with major GI surgical disorders


Inclusion Criteria:

All neonates ≥ 34 weeks gestational age with major GI surgical disorders (Gastroschisis,
omphalocele, volvulus, trachea-esophageal fistula, duodenal atresia, jejunal atresia, ileal
atresia, hirschsprung's disease, anorectal malformation, intestinal obstruction, and GI
perforations) requiring surgery admitted to our NICU within first 72 hours will be eligible
for this study

Exclusion Criteria:

1. If does not need TPN by 72 hours;

2. Direct hyperbilirubinemia within the first 72 hours after birth;

3. TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc);

4. Biliary tract disorders leading to direct hyperbilirubinemia;

5. Known metabolic disorders that may be associated with direct hyperbilirubinemia- such
as Galactosemia, α-1 antitrypsin deficiency, etc
We found this trial at
1
site
University of Rochester
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Kunal Gupta, MD
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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