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Omegaven Protocol:Intermediate Size Patient Population

NCT03561194 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2021-05-11

No results posted yet for this study

Summary

Children requiring prolonged courses of PN are at risk for developing PN associated liver disease. We hypothesize that although omega-6 fatty acid emulsions prevent fatty acid deficiency, they are not cleared in a manner similar to enteral chylomicrons and therefore accumulate in the liver and resulting in steatotic liver injury. We further hypothesize that a fat emulsion comprised of omega-3 fatty acids (i.e., fish oil) such as Omegaven® would be beneficial in the management of steatotic liver injury by its inhibition of de novo lipogenesis, the reduction of arachidonic acid-derived inflammatory mediators, prevention of essential fatty acid deficiency through the presence of small amounts of arachidonic acid, and improved clearance of lipids from the serum.

Conditions

  • Parenteral Nutrition Associated Liver Disease

Interventions

DIETARY_SUPPLEMENT

Omegaven

After the diagnosis of PNALD is made, patients who are followed by the Neonatal Intensive Care Unit, NICU, will contact Dr. Honrubia and Dr. Swarup. Cases may also include referrals of patients with PNALD from other healthcare facilities or self-referrals. If the patient's parents or guardians agree to participate in the study, informed consent will be obtained. The history of present illness and past medical history will be reviewed with the guardian and pertinent demographic and medical information will be recorded on data collection forms. This form will be used to record all laboratory results, nutritional history, and descriptions of any liver biopsies performed.

Sponsors & Collaborators

  • DHR Health Institute for Research and Development

    lead OTHER

Eligibility

Min Age
22 Weeks
Max Age
40 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03561194 on ClinicalTrials.gov