Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants

Stopped early · Not applicable

Conditions studied: Cholestasis, Prematurity, Gastroschisis, Intestinal Atresia, Necrotizing Enterocolitis

In brief

Hypothesis to be Tested: Since the first description of intravenous alimentation over half a century ago, parenteral nutrition (PN) has become a common nutritional intervention for conditions characterized by inability to tolerate enteral feeds such as Short Bowel Syndrome, Chronic Intestinal Pseudoobstruction, Microvillus Inclusion Disease, Crohn's disease, multi-organ failure and prematurity. Parenteral Nutrition-Associated Liver Disease (PNALD) encompasses a spectrum of disease including cholestasis, hepatitis, steatosis and gallbladder sludge/stones which may progress to liver cirrhosis and even failure. There is a direct correlation between duration of parenteral nutrition and development of cholestasis in infants. There is evidence in animals and humans that cycling of parental nutrition, defined as infusing nutrients over a time period shorter than 24 hours, reduces cholestasis. There is also data that premature infants with gestational age (GA) \< 32 weeks and birth weight \<1500g, as well as infants with congenital anomalies of the gastrointestinal tract, are among those at highest risk of developing Parenteral Nutrition-Associated Cholestasis (PNAC). We therefore hypothesize that infants with gestational age (GA) \<32 weeks and birth weight (BW) between \<1500g, or with congenital anomaly of the gastrointestinal tract regardless of GA or BW, receiving PN over a period of 20 hours will have a decrease severity of PNAC, demonstrated by a lower peak direct bilirubin, compared to a similar control population receiving standard 24 hour infusion.

Key facts

Study ID

NCT01062815

Run by

University of Miami

People needed

48

Starts

2009-02-01

Expected to finish

2010-06-01

Last updated by the study team

2015-11-23

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Holtz's Children's Hospital- University of Miami/Jackson Memorial Hospital — Miami, Florida, United States

Full record on ClinicalTrials.gov

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