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

Vanderbilt University Medical Center

Status and phase: Completed; Phase 4

Conditions: Parenteral Nutrition Associated Liver Disease

Treatments: Drug: Omegaven

Study type: Interventional

Funder types: Other

Identifiers

NCT00862446

080887

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 patients

Sex: All

Ages: Under 24 months old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Enrollment in another trial
• Lack of consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Treatment

Experimental group

Description:

All infants will receive Omegaven

Treatment:

Drug: Omegaven