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Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis

Primary Purpose

Parenteral Nutrition Associated Cholestasis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
intravenous lipid
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parenteral Nutrition Associated Cholestasis

Eligibility Criteria

undefined - 72 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

low dose intravenous lipids

high dose of intravenous lipids

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Parenteral Nutrition Associated Cholestasis
Defined as direct bilirubin ≥ 2mg/dl developing within one week of the completion of 6 week randomization period

Secondary Outcome Measures

Mean Rate of Change in Direct Bilirubin
Amount of direct (conjugated) bilirubin was measured from sera samples.

Full Information

First Posted
March 14, 2012
Last Updated
December 2, 2020
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT01555957
Brief Title
Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis
Official Title
Effect of Lipid Intake on Direct Hyperbilirubinemia in Late Preterm and Term Infants With Gastrointestinal Surgical Problems.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Rochester

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parenteral Nutrition Associated Cholestasis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low dose intravenous lipids
Arm Type
Experimental
Arm Title
high dose of intravenous lipids
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
intravenous lipid
Intervention Description
intravenous given daily for 6 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Parenteral Nutrition Associated Cholestasis
Description
Defined as direct bilirubin ≥ 2mg/dl developing within one week of the completion of 6 week randomization period
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Mean Rate of Change in Direct Bilirubin
Description
Amount of direct (conjugated) bilirubin was measured from sera samples.
Time Frame
baseline, weeks 1, 2, 3, 4, 5 and 6

10. Eligibility

Sex
All
Maximum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
No
Eligibility 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: If does not need TPN by 72 hours; Direct hyperbilirubinemia within the first 72 hours after birth; TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc); Biliary tract disorders leading to direct hyperbilirubinemia; Known metabolic disorders that may be associated with direct hyperbilirubinemia- such as Galactosemia, α-1 antitrypsin deficiency, etc
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjiv Amin, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kunal Gupta, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis

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