Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants
Cholestasis, Prematurity, Gastroschisis
About this trial
This is an interventional prevention trial for Cholestasis focused on measuring PNALD, PNAC, Parenteral Nutrition-Associated Cholestasis, Congenital Anomalies of Gastrointestinal Tract
Eligibility Criteria
Inclusion Criteria:
Infants expected to need prolonged PN (receiving >75% PN on dol 7) with the following risk factors:
- Prematurity with gestational age (GA) <32 weeks AND birth weight <1500g. OR
- Congenital anomaly of the gastrointestinal tract regardless of GA or BW
- Screening direct bilirubin prior to the initiation of parenteral nutrition <2mg/dL.
Exclusion Criteria:
- Infants with major congenital anomalies, other than those of the gastrointestinal tract.
- Infants with known obstruction of the hepatobiliary tract.
- Infants with suspected congenital infection or suspected genetic/metabolic syndrome predisposing them to cholestasis based on direct bilirubin > 2mg/dL prior to instituting PN.
Sites / Locations
- Holtz's Children's Hospital- University of Miami/Jackson Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Cycling Parenteral Nutrition
Continuous Parenteral Nutrition
Infants in the intervention cycling group will receive infusion of carbohydrate/amino acids and intralipid over a 20-hour period. During the 4-hour window period, infants in this group will receive dextrose solution only at the same rate calculated for the carbohydrate/amino acid infusion.
Infants in this control group will receive infusion of carbohydrates/amino acids and intralipids continuously, over 24 hours.