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

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00862446
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arm: 1
• Actual Duration (Months): 127
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Parenteral Nutrition Associated Liver Disease	Drug: Omegaven	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
• Actual Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Oct 1, 2019
• Actual Study Completion Date: Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment All infants will receive Omegaven	Drug: Omegaven; 1 gram/kg/day daily until on feeds

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Resolution of the Direct Hyperbilirubinemia [At discharge or up to 10 weeks]

   Defined as direct bilirubin <2.0 mg/dL

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 24 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Monroe Carell Jr Children's Hospital at vanderbilt	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• Vanderbilt University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 19, 2010

More Information

Publications

None provided.

• Responsible Party: Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT00862446
• Other Study ID Numbers: 080887
• First Posted: Mar 17, 2009
• Last Update Posted: Jan 5, 2021
• Last Verified: Dec 1, 2020

• Keywords provided by Vanderbilt University Medical Center: Parenteral nutrition associate liver disease; TPN cholestasis; TPN Associated Liver Disease
• Additional relevant MeSH terms: Liver Diseases

Study Results

Participant Flow

Arm/Group Title	Omegaven Treatment
Arm/Group Description	All participants received Omegaven: 1 gram/kg/day daily until they were able to ingest adequate nutrition enterally
Period Title: Overall Study
STARTED	48
COMPLETED	48
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Omegaven Treatment
Arm/Group Description	All participants received Omegaven: 1 gram/kg/day daily until they were able to ingest adequate nutrition enterally
Overall Participants	48
Age (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	63.875 (32.25)
Sex: Female, Male (Count of Participants)
Female	22 45.8%
Male	26 54.2%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	48 100%
Direct Bilirubin (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	6.25 (3.83)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Resolution of the Direct Hyperbilirubinemia
Description	Defined as direct bilirubin <2.0 mg/dL
Time Frame	At discharge or up to 10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omegaven Treatment
Arm/Group Description	All participants received Omegaven: 1 gram/kg/day daily until they were able to ingest adequate nutrition enterally
Measure Participants	48
Count of Participants [Participants]	29 60.4%

Adverse Events

Time Frame	Baseline to Week 10
Adverse Event Reporting Description	The only adverse collected were mortality, coagulopathy, hypertriglyceridemia
Arm/Group Title	Omegaven Treatment
Arm/Group Description	All participants received Omegaven: 1 gram/kg/day daily until they were able to ingest adequate nutrition enterally
All Cause Mortality
	Omegaven Treatment
	Affected / at Risk (%)	# Events
Total	6/48 (12.5%)
Serious Adverse Events
	Omegaven Treatment
	Affected / at Risk (%)	# Events
Total	5/48 (10.4%)
Blood and lymphatic system disorders
Coagulopathy	1/48 (2.1%)	1
Hypertriglyceridemia	5/48 (10.4%)	5
Other (Not Including Serious) Adverse Events
	Omegaven Treatment
	Affected / at Risk (%)	# Events
Total	0/48 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.