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Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Sanjiv Amin, 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: August 14, 2017
Last verified: August 2017
  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

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
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: 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
Study First Received: March 14, 2012
Last Updated: August 14, 2017

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

ClinicalTrials.gov processed this record on September 21, 2017