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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University of Miami.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT01062815
First received: February 3, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Cholestasis
Prematurity
Gastroschisis
Intestinal Atresia
Necrotizing Enterocolitis
Drug: Parenteral Nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: February 2009
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Parenteral Nutrition
Parenteral Nutrition infused over 20 hours cycled with dextrose solution over 4 hours compared to Parenteral Nutrition infused continuously over 24 hours.
No Intervention: Continuous Parenteral Nutrition
Infants in this control group will receive infusion of carbohydrates/amino acids and intralipids continuously, over 24 hours.
Drug: 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

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062815

Contacts
Contact: Jennifer Garcia, MD 305-243-3166 JGarcia2@med.miami.edu
Contact: Teresa DelMoral, MD 305-243-4531 TDelMoral@med.miami.edu

Locations
United States, Florida
Holtz's Children's Hospital- University of Miami/Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Jennifer Garcia, MD    305-243-3166    JGarcia2@med.miami.edu   
Contact: Teresa DelMoral, MD MPH    305-243-4531    TDelMoral@med.miami.ed   
Sub-Investigator: Jennifer Garcia, MD         
Sub-Investigator: Teresa DelMoral, MD, MPH         
Principal Investigator: Lesley Smith, MD, MBA         
Sponsors and Collaborators
University of Miami
Investigators
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
  More Information

No publications provided

Responsible Party: Lesley Smith MD MBA, University of Miami, Department of Pediatrics, Division of Gastroenterology, Hepatology and Nutrition
ClinicalTrials.gov Identifier: NCT01062815     History of Changes
Other Study ID Numbers: 20080651
Study First Received: February 3, 2010
Last Updated: February 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
PNALD
PNAC
Parenteral Nutrition-Associated Cholestasis
Congenital Anomalies of Gastrointestinal Tract

Additional relevant MeSH terms:
Cholestasis
Enterocolitis
Enterocolitis, Necrotizing
Gastroschisis
Intestinal Atresia
Bile Duct Diseases
Biliary Tract Diseases
Congenital Abnormalities
Digestive System Abnormalities
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Hernia
Hernia, Abdominal
Intestinal Diseases
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 27, 2014