Low Dose Fat for the Prevention of Liver Disease in Babies With Gastrointestinal Disorders
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Digestive Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/7/2015 |
| Start Date: | December 2010 |
| End Date: | December 2015 |
| Contact: | Kara L Calkins, MD |
| Email: | KCalkins@mednet.ucla.edu |
| Phone: | 310 206 6197 |
Low Dose Parenteral Fat for the Prevention of Parenteral Nutrition Associated Cholestasis in Neonates With Congenital/Acquired Gastrointestinal Disorders
Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral
Nutrition Associated Cholestasis (PNAC). Besides enteral nutrition, standard therapies to
prevent and treat PNAC have been limited and marginal. Recently, the dose and composition of
standard intravenous fat emulsions have implicated in the development and progression of
PNAC.
In this study, neonates with congenital/acquired gastrointestinal disorders will be
randomized, in a unblinded fashion, to receive either the standard dose of an intravenous
omega-6 fatty acid emulsion or a low dose of an intravenous omega-6 fatty acid emulsion
throughout their course of PN or until hospital discharge, death or 100 days of life,
whichever comes first. The primary outcome will be the presence of cholestasis at 28 days
or when full feeds are reached, whichever is longer.
Nutrition Associated Cholestasis (PNAC). Besides enteral nutrition, standard therapies to
prevent and treat PNAC have been limited and marginal. Recently, the dose and composition of
standard intravenous fat emulsions have implicated in the development and progression of
PNAC.
In this study, neonates with congenital/acquired gastrointestinal disorders will be
randomized, in a unblinded fashion, to receive either the standard dose of an intravenous
omega-6 fatty acid emulsion or a low dose of an intravenous omega-6 fatty acid emulsion
throughout their course of PN or until hospital discharge, death or 100 days of life,
whichever comes first. The primary outcome will be the presence of cholestasis at 28 days
or when full feeds are reached, whichever is longer.
Parenteral Nutrition (PN) acts as an intravenous source of both macronutrients and
micronutrients when enteral feeds are not possible. Intravenous fat emulsions often
supplement PN and provide a dense source of non-protein calories and essential fatty acids.
Although PN is life-sustaining, it is associated with a myriad of life-threatening
complications including Parenteral Nutrition Associated Cholestasis (PNAC). Children
dependent on PN for an extended period of time are high risk for liver failure.
The etiology of PNAC remains poorly understood. Neonates with congenital and acquired
gastrointestinal disorders are at high risk for PNAC and its subsequent complications.
Examples of these gastrointestinal disorders include gastroschisis, volvulus, atresias,
dysmotility and malabsorption disorders, pseudo-obstruction, and Hirschsprung's disease.
These disorders often render the gut non-functional for extended periods of time. As a
result, these patients become PN-dependent and develop PNAC.
Specific PN components have been implicated in the pathogenesis of PNAC. More recently,
standard intravenous fat emulsions have been labeled as one of the main culprits
contributing to PNAC. Standard intravenous fat emulsions are dosed as high as 4 mg/kg/d and
are derived from soybean and/or safflower oil, which are rich in omega-6 fatty acids and
contain a paucity of omega-3 fatty acids. It is unclear if the dose or high omega-6 fatty
acid:omega-3 fatty acid ratio is responsible for the development of PNAC.
The primary specific aim of this study is to determine if PNAC is related to the amount of
standard intravenous fat emulsion administered to neonates with congenital/acquired
gastrointestinal disorders. The investigators hypothesize that the PNAC is unrelated to the
dose of intravenous fat emulsions. To test this hypothesis, neonates with
congenital/acquired gastrointestinal disorders will be randomized to low dose standard
soybean based parenteral fat, 1 gm/kg/d, or standard dose soybean parenteral fat, 3 gm/kg/d.
Secondary outcomes include: mortality rate, length of stay, and anthropometric measurements
at 28 days of life and at the end of the hospital stay, which is expected to be an average
of 5 weeks.
micronutrients when enteral feeds are not possible. Intravenous fat emulsions often
supplement PN and provide a dense source of non-protein calories and essential fatty acids.
Although PN is life-sustaining, it is associated with a myriad of life-threatening
complications including Parenteral Nutrition Associated Cholestasis (PNAC). Children
dependent on PN for an extended period of time are high risk for liver failure.
The etiology of PNAC remains poorly understood. Neonates with congenital and acquired
gastrointestinal disorders are at high risk for PNAC and its subsequent complications.
Examples of these gastrointestinal disorders include gastroschisis, volvulus, atresias,
dysmotility and malabsorption disorders, pseudo-obstruction, and Hirschsprung's disease.
These disorders often render the gut non-functional for extended periods of time. As a
result, these patients become PN-dependent and develop PNAC.
Specific PN components have been implicated in the pathogenesis of PNAC. More recently,
standard intravenous fat emulsions have been labeled as one of the main culprits
contributing to PNAC. Standard intravenous fat emulsions are dosed as high as 4 mg/kg/d and
are derived from soybean and/or safflower oil, which are rich in omega-6 fatty acids and
contain a paucity of omega-3 fatty acids. It is unclear if the dose or high omega-6 fatty
acid:omega-3 fatty acid ratio is responsible for the development of PNAC.
The primary specific aim of this study is to determine if PNAC is related to the amount of
standard intravenous fat emulsion administered to neonates with congenital/acquired
gastrointestinal disorders. The investigators hypothesize that the PNAC is unrelated to the
dose of intravenous fat emulsions. To test this hypothesis, neonates with
congenital/acquired gastrointestinal disorders will be randomized to low dose standard
soybean based parenteral fat, 1 gm/kg/d, or standard dose soybean parenteral fat, 3 gm/kg/d.
Secondary outcomes include: mortality rate, length of stay, and anthropometric measurements
at 28 days of life and at the end of the hospital stay, which is expected to be an average
of 5 weeks.
Inclusion Criteria:
- congenital or acquired gastrointestinal disorder
- age less than 48 hours
Exclusion Criteria:
- congenital intrauterine infection know to be associated with liver involvement
- known structural liver abnormalities
- known genetic disorders (trisomy 21, 13, and 18)
- inborn errors of metabolism
- infants meeting the criteria for terminal illness (ph:6.8>2 hours)
We found this trial at
2
sites
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
Click here to add this to my saved trials
Click here to add this to my saved trials