Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2019-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Babies in the newborn intensive care unit who are dependent upon intravenous nutrition for a long period of time frequently develop liver damage. The fat used is called intralipid and is made from soybean oil. There is a suggestion in the literature that using fish oil based fats called omega-3 fat emulsions can decrease or even reverse this liver damage. We will offer babies with evidence of liver damage and no ability to eat,the Omegaven and see if the liver damage reverses.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Omegaven Treatment of Parenteral Nutrition (PN) Induced Liver Injury

NCT01089426

Liver Injury

COMPLETED NA

Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants

NCT02534077

Total Parenteral Nutrition-induced Cholestasis

APPROVED_FOR_MARKETING

Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury

NCT01845116

Total Parenteral Nutrition-induced Cholestasis

COMPLETED PHASE2

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

NCT01425567

Liver Disease

APPROVED_FOR_MARKETING

Compassionate Use of Omegaven® for the Treatment of Intestinal Failure Associated Liver Disease in Children

NCT02328768

Total Parenteral Nutrition-Induced Cholestasis

APPROVED_FOR_MARKETING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Babies in the newborn intensive care unit with evidence of liver damage from Total Parenteral Nutrition (TPN), as indicated by a direct bilirubin of greater than 2.5 , and who will not be fed for at least another month will be offered the trial. they will be changed from the intralipid to Omegaven as the source of their fat. We will continue routine monitoring of their nutrition and liver function.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parenteral Nutrition Associated Liver Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

All infants will receive Omegaven

Group Type EXPERIMENTAL

Omegaven

Intervention Type DRUG

1 gram/kg/day daily until on feeds

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Omegaven

1 gram/kg/day daily until on feeds

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Infants in the newborn intensive care unit
* TPN cholestasis of at least 2.5 mg/dl
* Anticipated TPN treatment for at least one month
* signed informed consent