Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis

NCT01555957 | Completed Phase 3 Results FDA Drug

• 1 other identifier: URochester
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Parenteral Nutrition Associated Cholestasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean Rate of Change in Direct Bilirubin

  baseline, weeks 1, 2, 3, 4, 5 and 6

Study Arms (2)

low dose intravenous lipids

EXPERIMENTAL

Drug: intravenous lipid

high dose of intravenous lipids

PLACEBO COMPARATOR

Drug: intravenous lipid

Interventions

intravenous lipid DRUG

intravenous given daily for 6 weeks

high dose of intravenous lipids; low dose intravenous lipids

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Fat Emulsions, Intravenous

Intervention Hierarchy (Ancestors)

Emulsions; Colloids; Dosage Forms; Pharmaceutical Preparations; Parenteral Nutrition Solutions; Pharmaceutical Solutions; Solutions; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Sanjiv Amin
• Organization: University of Rochester

sanjiv_amin@urmc.rochester.edu

585-273-2696

Study Officials

• Sanjiv Amin, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Kunal Gupta, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 16, 2012
• Study Start: February 1, 2012
• Primary Completion: October 30, 2018
• Study Completion: January 31, 2019
• Last Updated: December 3, 2020
• Results First Posted: December 3, 2020

Record last verified: 2020-12

Locations

US (1)