Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis

Effect of Lipid Intake on Direct Hyperbilirubinemia in Late Preterm and Term Infants With Gastrointestinal Surgical Problems.

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

Study Overview

• Status: Completed
• Conditions: Parenteral Nutrition Associated Cholestasis
• Intervention / Treatment: Drug: intravenous lipid

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Rate of Change in Direct Bilirubin	Amount of direct (conjugated) bilirubin was measured from sera samples.	baseline, weeks 1, 2, 3, 4, 5 and 6

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Sanjiv Amin, MD, University of Rochester; Principal Investigator: Kunal Gupta, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): October 30, 2018
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: March 14, 2012
• First Submitted That Met QC Criteria: March 14, 2012
• First Posted (Estimate): March 16, 2012

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis
• Other Study ID Numbers: URochester

Drug and device information, study documents

• 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