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Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01555957
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Sanjiv Amin, University of Rochester

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

Condition or disease Intervention/treatment Phase
Parenteral Nutrition Associated Cholestasis Drug: intravenous lipid Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: The care taker team provided daily weight to the research pharmacist for calculating the dose of the lipid according to the assignment and then calculated the rate of administration over 18 to 24 hours depending on the volume. The rate and dose was masked to the investigators and participants.
Primary Purpose: Prevention
Official Title: Effect of Lipid Intake on Direct Hyperbilirubinemia in Late Preterm and Term Infants With Gastrointestinal Surgical Problems.
Study Start Date : February 2012
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : January 31, 2019

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. Rate of increase in direct bilirubin [ Time Frame: 7 weeks ]


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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

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


Locations
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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Sanjiv Amin, MD University of Rochester
Principal Investigator: Kunal Gupta, MD University of Rochester

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Responsible Party: Sanjiv Amin, Professor of Pediatrics, University of Rochester
ClinicalTrials.gov Identifier: NCT01555957     History of Changes
Other Study ID Numbers: URochester
First Posted: March 16, 2012    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases