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

This study has been terminated.
(Difficulty in recruiting patients)
Sponsor:
Information provided by (Responsible Party):
Lesley Smith, University of Miami
ClinicalTrials.gov Identifier:
NCT01062815
First received: February 3, 2010
Last updated: November 20, 2015
Last verified: November 2015

February 3, 2010
November 20, 2015
February 2009
June 2010   (final data collection date for primary outcome measure)
The primary outcome is a decreased peak direct bilirubin in infants with GA <32 weeks and BW between <1500g, or with congenital anomaly of the gastrointestinal tract regardless of GA or BW, requiring prolonged PN (receiving >75% PN on dol 7). [ Time Frame: Peak direct bilirubin during time period: Initiation to Discontinuation of PN (Defined as successfully off PN for 7days) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01062815 on ClinicalTrials.gov Archive Site
  • A secondary outcome is to determine if the incidence of PN- Associated Cholestasis is lower in infants receiving cyclic PN over 20 hours compared to infants receiving standard continuous PN over 24 hours. [ Time Frame: Incidence of cholestasis (direct bilirubin >2mg/dL) during time period: Initiation to Discontinuation of PN (Defined as successfully off PN for 7days) ] [ Designated as safety issue: No ]
  • A secondary outcome in infants who develop PN-Associated Cholestasis is to evaluate if those receiving cyclic PN will have a shorter duration of cholestasis compared to infants receiving continuous PN. [ Time Frame: Duration of cholestasis (# of days direct bilirubin > 2mg/dL) during time period: Initiation to Discontinuation of PN (Defined as successfully off PN for 7days) . ] [ Designated as safety issue: No ]
  • A secondary outcome is to evaluate if infants receiving cyclic PN will have equivalent rates of growth compared to infants receiving continuous PN. [ Time Frame: Rate of growth (g of weight and cm of length and head circumference gained per week) during time period: Initiation to Discontinuation of PN (Defined as successfully off PN for 7days). ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants
Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Cholestasis
  • Prematurity
  • Gastroschisis
  • Intestinal Atresia
  • Necrotizing Enterocolitis
Dietary Supplement: Parenteral Nutrition
Parenteral Nutrition infused over 20 hours cycled with dextrose solution over 4 hours compared to Parenteral Nutrition infused continuously over 24 hours.
  • Experimental: 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.
    Intervention: Dietary Supplement: Parenteral Nutrition
  • Active Comparator: Continuous Parenteral Nutrition
    Infants in this control group will receive infusion of carbohydrates/amino acids and intralipids continuously, over 24 hours.
    Intervention: Dietary Supplement: Parenteral Nutrition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
48
June 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
up to 7 Days
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01062815
20080651
No
Not Provided
Not Provided
Lesley Smith, University of Miami
University of Miami
Not Provided
Principal Investigator: Lesley Smith, MD, MBA University of Miami, Dept of Pediatrics, Division of GI, Hepatology and Nutrition
Study Director: Jennifer Garcia, MD University of Miami, Dept of Pediatrics, Division of GI, Hepatology and Nutrition
Study Chair: Teresa DelMoral, MD MPH University of Miami, Dept of Pediatrics, Division of Neonatology
University of Miami
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP