Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants
| Status: | Terminated |
|---|---|
| Conditions: | Colitis, Women's Studies, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2009 |
| End Date: | June 2010 |
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.
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.
Inclusion Criteria:
1. Infants expected to need prolonged PN (receiving >75% PN on dol 7) with the following
risk factors:
1. Prematurity with gestational age (GA) <32 weeks AND birth weight <1500g. OR
2. Congenital anomaly of the gastrointestinal tract regardless of GA or BW
2. Screening direct bilirubin prior to the initiation of parenteral nutrition <2mg/dL.
Exclusion Criteria:
1. Infants with major congenital anomalies, other than those of the gastrointestinal
tract.
2. Infants with known obstruction of the hepatobiliary tract.
3. Infants with suspected congenital infection or suspected genetic/metabolic syndrome
predisposing them to cholestasis based on direct bilirubin > 2mg/dL prior to
instituting PN.
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