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Compassionate Use of IV Fish Oil for Parenteral Nutrition (PN) Liver Injury | Clinical Trials | Clareo Health

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Compassionate Use of IV Fish Oil for Parenteral Nutrition (PN) Liver Injury

Compassionate Use of an Intravenous Lipid Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Children

NCT01425567•The University of Texas Health Science Center at San Antonio

View on ClinicalTrials.gov

Summary

To establish a process by which critically ill infants with parenteral nutrition-associated liver disease can receive a fish oil-based intravenous lipid emulsion (Omegaven®) for compassionate use when no satisfactory alternative treatments are available.

Detailed Description

Patients who meet the inclusion criteria (having a direct bilirubin ≥4.0 mg/dL) and are consented will be discontinued from standard soybean-based lipid emulsion and started on Omegaven®. Omegaven® will be infused continuously via either a peripheral or central catheter at a dose of 1 gm/kg/day along with parenteral nutrition (PN).

Eligibility

Age

0 - 2 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•\- \>14 days \<24 months\* Anatomic short gut (\< 50 % bowel removed) with total bilirubin \> or = 4 mg/dL Or severe dysmotility of gut reflecting non functional gut with total bilirubin \> or = 4 mg/dL Receiving at least 60 % calories by intravenous infusion Requires IV nutrition an additional 28 days \* Patients with direct bilirubin \> or = 6 mg/dL who do not meet criteria above but meet criteria with \* If infants qualify for high risk ARM (gastroschisis, ileal atresia, \<750 grams and stage III NEC) d bilirubin \>1 mg/dL but less than 4 mg/dL.

Exclusion Criteria

•Congenital lethal condition (e.g. Trisomy 13) Clinically severe bleeding Evidence of viral hepatitis or primary liver disease as etiology of their cholestasis Other health problems such as survival extremely unlikely even if cholestasis improves Known allergies to eggs or shellfish

Locations (1)

University Health System

San Antonio, Texas, United States

Key Dates

Last Updated

February 12, 2019

Conditions

Liver Disease

Interventions

Intravenous Lipid Emulsion Comprised of Fish Oil

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Compassionate Use of IV Fish Oil for Parenteral Nutrition (PN) Liver Injury

Inclusion Criteria

Exclusion Criteria

Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry

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