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Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis

This study is currently recruiting participants.
Verified August 2017 by Sanjiv Amin, University of Rochester
Sponsor:
ClinicalTrials.gov Identifier:
NCT01555957
First Posted: March 16, 2012
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanjiv Amin, University of Rochester
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Sanjiv Amin, 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 ]

Secondary Outcome Measures:
  • peak direct bilirubin concentration during the hospital stay [ Time Frame: 7 weeks ]
  • percentage weight gain during the study period [ Time Frame: 6 weeks ]
  • use of choleretic medications [ Time Frame: 6 weeks ]
  • Use of Omegavan [ Time Frame: 6 weeks ]

Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: January 31, 2018
Estimated Primary Completion Date: January 31, 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sanjiv Amin, Associate Professor of Pediatrics, University of Rochester
ClinicalTrials.gov Identifier: NCT01555957     History of Changes
Other Study ID Numbers: URochester
First Submitted: March 14, 2012
First Posted: March 16, 2012
Last Update Posted: August 17, 2017
Last Verified: August 2017

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