NCT01373918

Brief Summary

Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral Nutrition Associated Cholestasis (PNAC). Besides enteral nutrition, standard therapies to prevent and treat PNAC have been limited and marginal. Recently, the dose and composition of standard intravenous fat emulsions have implicated in the development and progression of PNAC. In this study, neonates with congenital/acquired gastrointestinal disorders will be randomized, in a unblinded fashion, to receive either the standard dose of an intravenous omega-6 fatty acid emulsion or a low dose of an intravenous omega-6 fatty acid emulsion throughout their course of PN or until hospital discharge, death or 100 days of life, whichever comes first. The primary outcome will be the presence of cholestasis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2010

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
2 years until next milestone

Results Posted

Study results publicly available

June 16, 2016

Completed
Last Updated

June 16, 2016

Status Verified

May 1, 2016

Enrollment Period

3.6 years

First QC Date

June 6, 2011

Results QC Date

February 22, 2016

Last Update Submit

May 10, 2016

Conditions

Cholestasis

Keywords

cholestasisneonatesparenteral nutritiongastrointestinal disorders

Outcome Measures

Primary Outcomes (1)

  • Presence of Cholestasis

    Cholestasis will be defined by a direct bilirubin \> 2 mg/dL

    prior to 100 days of life, hospital discharge, or death whichever comes first

Secondary Outcomes (3)

  • Mortality Rate

    at the end of the hospital stay which is expected to be an average of 5 weeks

  • Anthropometric Measurements

    28 days of age

  • Anthropometric Measurements

    approximately 5 weeks

Study Arms (2)

low dose intravenous fat emulsion

EXPERIMENTAL

Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).

Drug: Intralipid

standard dose intravenous fat emulsion

ACTIVE COMPARATOR

Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).

Drug: Intralipid

Interventions

IntralipidDRUG

The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first.

Also known as: soybean oil
low dose intravenous fat emulsion

Eligibility Criteria

Age1 Minute - 5 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • congenital or acquired gastrointestinal disorder
  • age less than 5 days of life

You may not qualify if:

  • congenital intrauterine infection know to be associated with liver involvement
  • known structural liver abnormalities
  • known genetic disorders (trisomy 21, 13, and 18)
  • inborn errors of metabolism
  • infants meeting the criteria for terminal illness (ph:6.8\>2 hours)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

MeSH Terms

Conditions

CholestasisHyperphagiaGastrointestinal Diseases

Interventions

soybean oil, phospholipid emulsionSoybean Oil

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Limitations and Caveats

Early termination leading to small number of subjects analyzed.

Results Point of Contact

Title
Dr. Kara L. Calkins
Organization
University of California, Los Angeles
KCalkins@mednet.ucla.edu
310 825-9330

Study Officials

  • Kara L Calkins, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 6, 2011

First Posted

June 15, 2011

Study Start

December 1, 2010

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

June 16, 2016

Results First Posted

June 16, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)