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Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis

This study is currently recruiting participants.
Verified March 2013 by University of Rochester
Sponsor:
Information provided by (Responsible Party):
sanjiv amin, University of Rochester
ClinicalTrials.gov Identifier:
NCT01555957
First received: March 14, 2012
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in late preterm and term neonates with major GI surgical disorders


Condition Intervention Phase
Parenteral Nutrition Associated Cholestasis
 Drug: intravenous lipid
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effect of Lipid Intake on Direct Hyperbilirubinemia in Late Preterm and Term Infants With Gastrointestinal Surgical Problems.

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Parenteral Nutrition Associated Cholestasis will be the primary outcome measure and will be defined as direct bilirubin ≥ 2mg/dl developing within one week of the completion of 6 week randomization period [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • peak direct bilirubin concentration during the hospital stay [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
  • percentage weight gain during the study period [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • use of choleretic medications [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Use of Omegavan [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: low dose intravenous lipids Drug: intravenous lipid
intravenous given daily for 6 weeks
Placebo Comparator: high dose of intravenous lipids Drug: intravenous lipid
intravenous given daily for 6 weeks

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All neonates ≥ 34 weeks gestational age with major GI surgical disorders (Gastroschisis, omphalocele, volvulus, trachea-esophageal fistula, duodenal atresia, jejunal atresia, ileal atresia, hirschsprung's disease, anorectal malformation, intestinal obstruction, and GI perforations) requiring surgery admitted to our NICU within first 72 hours will be eligible for this study

Exclusion Criteria:

  1. If does not need TPN by 72 hours;
  2. Direct hyperbilirubinemia within the first 72 hours after birth;
  3. TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc);
  4. Biliary tract disorders leading to direct hyperbilirubinemia;
  5. Known metabolic disorders that may be associated with direct hyperbilirubinemia- such as Galactosemia, α-1 antitrypsin deficiency, etc
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555957

Contacts
Contact: Sanjiv Amin, MD, MS 5852732696 sanjiv_amin@urmc.rochester.edu
Contact: Kunal Gupta, MD 5852763964 kunal_gupta@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Sanjiv Amin, MD, MS         sanjiv_amin@urmc.rochester.edu    
Contact: Kunal Gupta, MD         Kunal_gupta@urmc.rochester.edu    
Principal Investigator: Kunal Gupta, MD            
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Sanjiv Amin, MD University of Rochester
Principal Investigator: Kunal Gupta, MD University of Rochester
  More Information

No publications provided

Responsible Party: sanjiv amin, Associate Professor of Pediatrics, University of Rochester
ClinicalTrials.gov Identifier: NCT01555957     History of Changes
Other Study ID Numbers: URochester
Study First Received: March 14, 2012
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013