Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants
NCT ID: NCT01062815
Last Updated: 2015-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
48 participants
INTERVENTIONAL
2009-02-28
2010-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Cycling 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.
Parenteral Nutrition
Parenteral Nutrition infused over 20 hours cycled with dextrose solution over 4 hours compared to Parenteral Nutrition infused continuously over 24 hours.
Continuous Parenteral Nutrition
Infants in this control group will receive infusion of carbohydrates/amino acids and intralipids continuously, over 24 hours.
Parenteral Nutrition
Parenteral Nutrition infused over 20 hours cycled with dextrose solution over 4 hours compared to Parenteral Nutrition infused continuously over 24 hours.
Interventions
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Parenteral Nutrition
Parenteral Nutrition infused over 20 hours cycled with dextrose solution over 4 hours compared to Parenteral Nutrition infused continuously over 24 hours.
Eligibility Criteria
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Inclusion Criteria
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
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.
7 Days
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Lesley Smith
Professor
Principal Investigators
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Lesley Smith, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
University of Miami, Dept of Pediatrics, Division of GI, Hepatology and Nutrition
Jennifer Garcia, MD
Role: STUDY_DIRECTOR
University of Miami, Dept of Pediatrics, Division of GI, Hepatology and Nutrition
Teresa DelMoral, MD MPH
Role: STUDY_CHAIR
University of Miami, Dept of Pediatrics, Division of Neonatology
Locations
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Holtz's Children's Hospital- University of Miami/Jackson Memorial Hospital
Miami, Florida, United States
Countries
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References
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Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
Other Identifiers
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20080651
Identifier Type: -
Identifier Source: org_study_id