Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants
NCT ID: NCT00738101
Last Updated: 2021-05-28
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
293 participants
Study Classification
INTERVENTIONAL
Study Start Date
2008-09-30
Study Completion Date
2020-03-27
Brief Summary
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To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.
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Detailed Description
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Inpatient Use of Omegaven:
Each family will have the severity of their child's condition explained to them and the available data regarding the benefit of the novel preparation explained using the preliminary safety and efficacy data from Boston Children's Hospital and TCH. Families will have the potential risks and benefits of the product explained. The lack of long-term follow-up information regarding the effects of Omegaven will be discussed.
Bottles containing 50mL or 100 mL of 10% Omegaven will be purchased from International Pharmacy of Hamburg, Germany. Omegaven is manufactured by Fresenius Kabi AG, Bad Homburg v.d.h, Germany. Omegaven is formulated as an emulsion from fish oils. The family (or legal guardian) will be billed for the Omegaven as part of their hospital bill from Texas Children's Hospital.
Omegaven will be dispensed per Texas Children's Hospital policy and procedures for fat emulsions.
All study materials will be stored securely until the time of administration. The bottles will be stored at room temperature below 30° C (do not freeze). Damaged or suspect drug will be returned unused to Fresenius- Kabi. Containers should be shaken before use.
All supplies for the study will be accompanied by accountability and shipping documents and will be maintained by the Investigator or deputy (e.g. research pharmacist). Information recorded on these accountability and shipping documents will include relevant dates, batch numbers, quantities received or dispensed, to whom dispensed, returned drug, and drug lost or damaged. At the end of the study, all used and unused Omegaven will be accounted for. If expired, the remaining drug supplies will be destroyed.
Details of Omegaven Administration:
Therapy with Omegaven will be provided at a dose of 1 gm/kg/day (by continuous infusion). Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. Parenteral fat emulsion (Intralipid) will be administered only if necessary to administer adequate calories during Omegaven therapy. The same standards of care provided to all patients receiving parenteral nutrition solution will be followed.
Ongoing monitoring during therapy related to safety and efficacy:
Safety will be assessed using the following outcome variables.
First, we will calculate the number (total and daily rate) of bloodstream infections prior to therapy. We will monitor this rate in each baby receiving Omegaven and compare with the previous rate. Currently, the rate of infection in infants receiving Omegaven is about half of the historical control rate at TCH.
Second, we will monitor growth rate using weight, length and head circumference growth. Growth will be compared both to the pre-treatment period and the expected rate of growth. We have established and have guidelines for optimal growth targets and management will be targeted on achieving these rates. We will monitor these carefully. For babies in the NICU or Level 2 nurseries, Dr. Abrams will supervise the nutritional management directly. Infants in the PICU or PCU will be followed by Dr. Carter with the critical care staff. This approach has been in place for the current group of 16 infants and growth has been excellent although final calculations are pending.
Third, we will monitor infants who are not receiving any enteral feeding at all for more than 4 weeks for any evidence of essential fatty acid (EFA) deficiency. Measurements will be repeated at the end of every 4 weeks that the subject remains without any enteral nutrition intake. Although the exact value suggestive of a deficiency is controversial, usually a level greater than 0.4 is considered evidence of EFA deficiency. This measurement may be made using 0.2 mL of serum in the lab of Dr. William Heird. Samples will be drawn monthly for infants who are NPO and run as a batch in Dr. Heird's lab in the CNRC every 6 months. Because data are not available for clinical use, we will include in the consent the possibility of EFA deficiency. We note again that no infant ever treated with Omegaven has ever shown clinical evidence of EFA deficiency, that very transient mild deficiency may occur in about 5% of infants and that there is no clinical intervention we would use in this case or that has ever been given without clinically apparent EFA deficiency.
Fourth, we will record and monitor the following lab and clinical results for the DSMB: electrolytes, calcium, phosphorus, magnesium, alkaline phosphatase, glucose, triglycerides, BUN, creatinine, conjugated and unconjugated bilirubin, albumin, prealbumin, CRP, WBC, RBC, platelets, PT, PTT, any evidence of bleeding, and positive blood cultures. These labs will be drawn as clinically relevant, not as a specific result of the study.
Finally, with regard to developmental follow-up we will indicate to families that all infants with cholestasis may be at risk for developmental delays and recommend that they be followed. There is no mechanism in place to assure this follow-up occurs for any infants in the TCH nurseries however.
Dose Modification
Hypertriglyceridemia:
If hypertriglyceridemia develops, defined as serum triglyceride levels \> 300 mg/dL, the following will be considered prior to reducing the dose:
1. If the level was obtained while the patient was receiving a continuous 24- hour infusion of Omegaven, the total dose should be infused over 20 hours, and a repeat serum triglyceride level obtained prior to resuming the infusion 4 hours later.
2. Other sources of hypertriglyceridemia should be considered and addressed (drugs, renal disease)
If necessary if the triglycerides continue to remain high despite the aforementioned interventions, a dosage reduction of 25% will be considered.
Duration of Therapy
Patients will remain on Omegaven until weaned from PN.
In the event that a patient who has been listed for a liver or liver/intestinal transplant has an organ become available, the participation in this protocol will not preclude them from receiving the transplant. Omegaven will not be administered post transplant.
Treatment will be given for as long as the child needs any TPN AND has a conjugated bilirubin greater than 2 mg/dL for a maximum of 5 years. If the infant no longer is requiring any TPN, then the Omegaven will be stopped regardless of bilirubin. If the bilirubin is less than 2 mg/dL but the child still requires TPN, then the Omegaven will be continued up to a total of 5 years or whenever the infant no longer requires TPN. The reason for stopping Omegaven when the infant no longer requires TPN is that this would be the only reason many infants would still need IV access and therefore the risk of maintaining IV access only for the medication is likely to exceed the benefit of Omegaven at that point.
Legal and Ethics Requirements:
This study has been approved by the BCM IRB under a FDA Investigational New Drug Application using IND #102,843.
The Investigators will be responsible for obtaining an Informed Consent signed by each patient or his/her legally authorized representative prior to his/her participation in the study in accordance with the Code of Federal Regulations, Title 21, Part 50.20. Informed Consent will be obtained from a patient or his/her legally authorized representative after a full explanation of the purpose of the study, the risks and discomforts involved, potential benefits, etc. have been provided by the Investigator or designee, both verbally and in writing. The person who signed the consent will be given a copy of the signed consent form. The lack of long-term follow-up information regarding the effects of Omegaven will be discussed.
Home Use of Omegaven:
In order for a subject to receive the Omegaven® at home through the home health care agency, subjects will first be required to be admitted to Texas Children's Hospital for 72 hours in initiate the administration of the Omegaven®. This will allow time for observation of any unexpected side effects and for parents to be provided education on home TPN and Omegaven®.
If a subject has already received Omegaven® either at TCH or at another hospital, they will not be required to be admitted for the 72 hour inpatient admission prior to starting Omegaven® at home. Parent training will occur during the previous hospital admission and will continue through the TCH Pediatric Intestinal Rehabilitation Clinic.
This population will include infants up to 5 years of age. The Omegaven® dose for home use will be the same as that used while in the hospital: 1 gm/kg/day. As with the inpatient part of the protocol, this is a maximum dose and may be decreased at the discretion of the TCH Pediatric Intestinal Rehabilitation Clinic Team.
Outpatient Monitoring:
After the initial evaluation by the TCH Pediatric Intestinal Rehabilitation Clinic physicians, subjects will return to the clinic for routine follow-up. Subjects will be asked to return to the clinic every 2 weeks for the first 2 months of treatment. Thereafter, subjects will return to the clinic on a monthly basis, or as directed by the clinic team. Orders for home use of Omegaven® will be signed by the physician at the clinic visits, ensuring that subjects are compliant with study parameters while receiving the treatment drug.
Routine monitoring done at clinic appointments and at home will be recorded for study purposes and data collection. No blood work will be done for study purposes only. Lab monitoring will typically be done every week to two weeks at home and at each clinic visit.
FDA Contact:
Division of Gastroenterology and Inborn Errors Products Division of Drug Information (DDI) (855) 543-3784 or (301) 796-3400; [email protected]
Each family will have the severity of their child's condition explained to them and the available data regarding the benefit of the novel preparation explained using the preliminary safety and efficacy data from Boston Children's Hospital and TCH. Families will have the potential risks and benefits of the product explained. The lack of long-term follow-up information regarding the effects of Omegaven will be discussed.
Bottles containing 50mL or 100 mL of 10% Omegaven will be purchased from International Pharmacy of Hamburg, Germany. Omegaven is manufactured by Fresenius Kabi AG, Bad Homburg v.d.h, Germany. Omegaven is formulated as an emulsion from fish oils. The family (or legal guardian) will be billed for the Omegaven as part of their hospital bill from Texas Children's Hospital.
Omegaven will be dispensed per Texas Children's Hospital policy and procedures for fat emulsions.
All study materials will be stored securely until the time of administration. The bottles will be stored at room temperature below 30° C (do not freeze). Damaged or suspect drug will be returned unused to Fresenius- Kabi. Containers should be shaken before use.
All supplies for the study will be accompanied by accountability and shipping documents and will be maintained by the Investigator or deputy (e.g. research pharmacist). Information recorded on these accountability and shipping documents will include relevant dates, batch numbers, quantities received or dispensed, to whom dispensed, returned drug, and drug lost or damaged. At the end of the study, all used and unused Omegaven will be accounted for. If expired, the remaining drug supplies will be destroyed.
Details of Omegaven Administration:
Therapy with Omegaven will be provided at a dose of 1 gm/kg/day (by continuous infusion). Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. Parenteral fat emulsion (Intralipid) will be administered only if necessary to administer adequate calories during Omegaven therapy. The same standards of care provided to all patients receiving parenteral nutrition solution will be followed.
Ongoing monitoring during therapy related to safety and efficacy:
Safety will be assessed using the following outcome variables.
First, we will calculate the number (total and daily rate) of bloodstream infections prior to therapy. We will monitor this rate in each baby receiving Omegaven and compare with the previous rate. Currently, the rate of infection in infants receiving Omegaven is about half of the historical control rate at TCH.
Second, we will monitor growth rate using weight, length and head circumference growth. Growth will be compared both to the pre-treatment period and the expected rate of growth. We have established and have guidelines for optimal growth targets and management will be targeted on achieving these rates. We will monitor these carefully. For babies in the NICU or Level 2 nurseries, Dr. Abrams will supervise the nutritional management directly. Infants in the PICU or PCU will be followed by Dr. Carter with the critical care staff. This approach has been in place for the current group of 16 infants and growth has been excellent although final calculations are pending.
Third, we will monitor infants who are not receiving any enteral feeding at all for more than 4 weeks for any evidence of essential fatty acid (EFA) deficiency. Measurements will be repeated at the end of every 4 weeks that the subject remains without any enteral nutrition intake. Although the exact value suggestive of a deficiency is controversial, usually a level greater than 0.4 is considered evidence of EFA deficiency. This measurement may be made using 0.2 mL of serum in the lab of Dr. William Heird. Samples will be drawn monthly for infants who are NPO and run as a batch in Dr. Heird's lab in the CNRC every 6 months. Because data are not available for clinical use, we will include in the consent the possibility of EFA deficiency. We note again that no infant ever treated with Omegaven has ever shown clinical evidence of EFA deficiency, that very transient mild deficiency may occur in about 5% of infants and that there is no clinical intervention we would use in this case or that has ever been given without clinically apparent EFA deficiency.
Fourth, we will record and monitor the following lab and clinical results for the DSMB: electrolytes, calcium, phosphorus, magnesium, alkaline phosphatase, glucose, triglycerides, BUN, creatinine, conjugated and unconjugated bilirubin, albumin, prealbumin, CRP, WBC, RBC, platelets, PT, PTT, any evidence of bleeding, and positive blood cultures. These labs will be drawn as clinically relevant, not as a specific result of the study.
Finally, with regard to developmental follow-up we will indicate to families that all infants with cholestasis may be at risk for developmental delays and recommend that they be followed. There is no mechanism in place to assure this follow-up occurs for any infants in the TCH nurseries however.
Dose Modification
Hypertriglyceridemia:
If hypertriglyceridemia develops, defined as serum triglyceride levels \> 300 mg/dL, the following will be considered prior to reducing the dose:
1. If the level was obtained while the patient was receiving a continuous 24- hour infusion of Omegaven, the total dose should be infused over 20 hours, and a repeat serum triglyceride level obtained prior to resuming the infusion 4 hours later.
2. Other sources of hypertriglyceridemia should be considered and addressed (drugs, renal disease)
If necessary if the triglycerides continue to remain high despite the aforementioned interventions, a dosage reduction of 25% will be considered.
Duration of Therapy
Patients will remain on Omegaven until weaned from PN.
In the event that a patient who has been listed for a liver or liver/intestinal transplant has an organ become available, the participation in this protocol will not preclude them from receiving the transplant. Omegaven will not be administered post transplant.
Treatment will be given for as long as the child needs any TPN AND has a conjugated bilirubin greater than 2 mg/dL for a maximum of 5 years. If the infant no longer is requiring any TPN, then the Omegaven will be stopped regardless of bilirubin. If the bilirubin is less than 2 mg/dL but the child still requires TPN, then the Omegaven will be continued up to a total of 5 years or whenever the infant no longer requires TPN. The reason for stopping Omegaven when the infant no longer requires TPN is that this would be the only reason many infants would still need IV access and therefore the risk of maintaining IV access only for the medication is likely to exceed the benefit of Omegaven at that point.
Legal and Ethics Requirements:
This study has been approved by the BCM IRB under a FDA Investigational New Drug Application using IND #102,843.
The Investigators will be responsible for obtaining an Informed Consent signed by each patient or his/her legally authorized representative prior to his/her participation in the study in accordance with the Code of Federal Regulations, Title 21, Part 50.20. Informed Consent will be obtained from a patient or his/her legally authorized representative after a full explanation of the purpose of the study, the risks and discomforts involved, potential benefits, etc. have been provided by the Investigator or designee, both verbally and in writing. The person who signed the consent will be given a copy of the signed consent form. The lack of long-term follow-up information regarding the effects of Omegaven will be discussed.
Home Use of Omegaven:
In order for a subject to receive the Omegaven® at home through the home health care agency, subjects will first be required to be admitted to Texas Children's Hospital for 72 hours in initiate the administration of the Omegaven®. This will allow time for observation of any unexpected side effects and for parents to be provided education on home TPN and Omegaven®.
If a subject has already received Omegaven® either at TCH or at another hospital, they will not be required to be admitted for the 72 hour inpatient admission prior to starting Omegaven® at home. Parent training will occur during the previous hospital admission and will continue through the TCH Pediatric Intestinal Rehabilitation Clinic.
This population will include infants up to 5 years of age. The Omegaven® dose for home use will be the same as that used while in the hospital: 1 gm/kg/day. As with the inpatient part of the protocol, this is a maximum dose and may be decreased at the discretion of the TCH Pediatric Intestinal Rehabilitation Clinic Team.
Outpatient Monitoring:
After the initial evaluation by the TCH Pediatric Intestinal Rehabilitation Clinic physicians, subjects will return to the clinic for routine follow-up. Subjects will be asked to return to the clinic every 2 weeks for the first 2 months of treatment. Thereafter, subjects will return to the clinic on a monthly basis, or as directed by the clinic team. Orders for home use of Omegaven® will be signed by the physician at the clinic visits, ensuring that subjects are compliant with study parameters while receiving the treatment drug.
Routine monitoring done at clinic appointments and at home will be recorded for study purposes and data collection. No blood work will be done for study purposes only. Lab monitoring will typically be done every week to two weeks at home and at each clinic visit.
FDA Contact:
Division of Gastroenterology and Inborn Errors Products Division of Drug Information (DDI) (855) 543-3784 or (301) 796-3400; [email protected]
Conditions
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Cholestasis
Cholestasis of Parenteral Nutrition
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Initiation of Study is defined as the day the Fish Oil Emulsion was initiated.
End of Study (EOS) is defined as discontinuation of fish oil emulsion, death, transplant, or discharge from the hospital.
In infants who meet the eligibility criteria for Fish Oil Emulsion arm will receive Fish Oil Emulsion after enrollment under the study. Therapy with Fish Oil Emulsion (Omegaven) will be provided at a dose of 1 gm/kg/day (by continuous infusion) and will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. If previously on Intralipid, it will be stopped prior to initiation of Fish Oil Emulsion.
End of Study (EOS) is defined as discontinuation of fish oil emulsion, death, transplant, or discharge from the hospital.
In infants who meet the eligibility criteria for Fish Oil Emulsion arm will receive Fish Oil Emulsion after enrollment under the study. Therapy with Fish Oil Emulsion (Omegaven) will be provided at a dose of 1 gm/kg/day (by continuous infusion) and will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. If previously on Intralipid, it will be stopped prior to initiation of Fish Oil Emulsion.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Open Label
Study Groups
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Fish Oil Emulsion Arm
In infants who meet the eligibility criteria for Fish Oil Emulsion arm will receive Fish Oil Emulsion after enrollment under the study.
Therapy with Fish Oil Emulsion (Omegaven) will be provided at a dose of 1 gm/kg/day (by continuous infusion) and will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. If previously on Intralipid, it will be stopped prior to initiation of Fish Oil Emulsion.Fish oil emulsion will be provided as a continuous intravenous emulsion over 24 hours.
Group Type
EXPERIMENTAL
Omegaven
Intervention Type
DRUG
Therapy with Omegaven will be provided at a dose of 1 gm/kg/day (by continuous infusion). Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. Treatment will be given for as long as the child needs any TPN AND has a conjugated bilirubin greater than 2 mg/dL for a maximum of 5 years. If the infant no longer is requiring any TPN, then the Omegaven will be stopped regardless of bilirubin. If the bilirubin is less than 2 mg/dL but the child still requires TPN, then the Omegaven will be continued until the infant no longer requires TPN.
Interventions
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Omegaven
Therapy with Omegaven will be provided at a dose of 1 gm/kg/day (by continuous infusion). Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. Treatment will be given for as long as the child needs any TPN AND has a conjugated bilirubin greater than 2 mg/dL for a maximum of 5 years. If the infant no longer is requiring any TPN, then the Omegaven will be stopped regardless of bilirubin. If the bilirubin is less than 2 mg/dL but the child still requires TPN, then the Omegaven will be continued until the infant no longer requires TPN.
Intervention Type
DRUG
Other Intervention Names
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Omega-3 enriched fat emulsion
Eligibility Criteria
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Inclusion Criteria
* Be greater than 14 days old and less than 5 years old
* Conjugated bilirubin greater than 2 mg/dL.
* Be expected to require intravenous nutrition for at least an additional 28 days
* Conjugated bilirubin greater than 2 mg/dL.
* Be expected to require intravenous nutrition for at least an additional 28 days
Exclusion Criteria
* Have a congenitally lethal condition (e.g. Trisomy 13).
* Have clinically severe bleeding not able to be managed with routine measures.
* Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
* Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.
Home Use of Omegaven®:
In order for a subject to receive the Omegaven® at home through a home health care agency, subjects will first be required to be admitted to Texas Children's Hospital for 72 hours in initiate the administration of the Omegaven®. This will allow time for observation of any unexpected side effects and for parents to be provided education on home TPN and Omegaven®.
If a subject has already received Omegaven® either at TCH or at another hospital, they will not be required to be admitted for the 72 hour inpatient admission prior to starting Omegaven® at home. Parent training will occur during the previous hospital admission and will continue through the TCH Pediatric Intestinal Rehabilitation Clinic.
Outpatient Monitoring:
After the initial evaluation by the TCH Pediatric Intestinal Rehabilitation Clinic physicians, subjects will return to the clinic for routine follow-up. Subjects will be asked to return to the clinic every 2 weeks for the first 2 months of treatment. Thereafter, subjects will return to the clinic on a monthly basis, or as directed by the clinic team.
* Have clinically severe bleeding not able to be managed with routine measures.
* Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
* Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.
Home Use of Omegaven®:
In order for a subject to receive the Omegaven® at home through a home health care agency, subjects will first be required to be admitted to Texas Children's Hospital for 72 hours in initiate the administration of the Omegaven®. This will allow time for observation of any unexpected side effects and for parents to be provided education on home TPN and Omegaven®.
If a subject has already received Omegaven® either at TCH or at another hospital, they will not be required to be admitted for the 72 hour inpatient admission prior to starting Omegaven® at home. Parent training will occur during the previous hospital admission and will continue through the TCH Pediatric Intestinal Rehabilitation Clinic.
Outpatient Monitoring:
After the initial evaluation by the TCH Pediatric Intestinal Rehabilitation Clinic physicians, subjects will return to the clinic for routine follow-up. Subjects will be asked to return to the clinic every 2 weeks for the first 2 months of treatment. Thereafter, subjects will return to the clinic on a monthly basis, or as directed by the clinic team.
Minimum Eligible Age
14 Days
Maximum Eligible Age
5 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Boston Children's Hospital
OTHER
Sponsor Role
collaborator
Baylor College of Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Muralidhar Premkumar
Assistant Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Murali Premkumar, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Baylor College of Medicine
Houston, Texas, United States
Site Status
Texas Children's Hospital
Houston, Texas, United States
Site Status
Countries
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United States
References
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Dudrick SJ, Wilmore DW, Vars HM, Rhoads JE. Long-term total parenteral nutrition with growth, development, and positive nitrogen balance. Surgery. 1968 Jul;64(1):134-42. No abstract available.
Reference Type
BACKGROUND
Wilmore DW, Dudrick SJ. Growth and development of an infant receiving all nutrients exclusively by vein. JAMA. 1968 Mar 4;203(10):860-4. No abstract available.
Reference Type
BACKGROUND
Mullick FG, Moran CA, Ishak KG. Total parenteral nutrition: a histopathologic analysis of the liver changes in 20 children. Mod Pathol. 1994 Feb;7(2):190-4.
Reference Type
BACKGROUND
Freund HR. Abnormalities of liver function and hepatic damage associated with total parenteral nutrition. Nutrition. 1991 Jan-Feb;7(1):1-5; discussion 5-6.
Reference Type
BACKGROUND
Beath SV, Davies P, Papadopoulou A, Khan AR, Buick RG, Corkery JJ, Gornall P, Booth IW. Parenteral nutrition-related cholestasis in postsurgical neonates: multivariate analysis of risk factors. J Pediatr Surg. 1996 Apr;31(4):604-6. doi: 10.1016/s0022-3468(96)90507-2.
Reference Type
BACKGROUND
Greenberg GR, Wolman SL, Christofides ND, Bloom SR, Jeejeebhoy KN. Effect of total parenteral nutrition on gut hormone release in humans. Gastroenterology. 1981 May;80(5 pt 1):988-93. No abstract available.
Reference Type
BACKGROUND
Yeh SL, Chen WJ, Huang PC. Effects of L-glutamine on induced hepatosteatosis in rats receiving total parenteral nutrition. J Formos Med Assoc. 1995 Oct;94(10):593-9.
Reference Type
BACKGROUND
Kubota A, Yonekura T, Hoki M, Oyanagi H, Kawahara H, Yagi M, Imura K, Iiboshi Y, Wasa K, Kamata S, Okada A. Total parenteral nutrition-associated intrahepatic cholestasis in infants: 25 years' experience. J Pediatr Surg. 2000 Jul;35(7):1049-51. doi: 10.1053/jpsu.2000.7769.
Reference Type
BACKGROUND
Moss RL, Das JB, Ansari G, Raffensperger JG. Hepatobiliary dysfunction during total parenteral nutrition is caused by infusate, not the route of administration. J Pediatr Surg. 1993 Mar;28(3):391-6; discussion 396-7. doi: 10.1016/0022-3468(93)90238-g.
Reference Type
BACKGROUND
Helms RA, Christensen ML, Mauer EC, Storm MC. Comparison of a pediatric versus standard amino acid formulation in preterm neonates requiring parenteral nutrition. J Pediatr. 1987 Mar;110(3):466-70. doi: 10.1016/s0022-3476(87)80519-x. No abstract available.
Reference Type
BACKGROUND
Moss RL, Haynes AL, Pastuszyn A, Glew RH. Methionine infusion reproduces liver injury of parenteral nutrition cholestasis. Pediatr Res. 1999 May;45(5 Pt 1):664-8. doi: 10.1203/00006450-199905010-00009.
Reference Type
BACKGROUND
Meehan JJ, Georgeson KE. Prevention of liver failure in parenteral nutrition-dependent children with short bowel syndrome. J Pediatr Surg. 1997 Mar;32(3):473-5. doi: 10.1016/s0022-3468(97)90609-6.
Reference Type
BACKGROUND
Whalen GF, Shamberger RC, Perez-Atayde A, Folkman J. A proposed cause for the hepatic dysfunction associated with parenteral nutrition. J Pediatr Surg. 1990 Jun;25(6):622-6. doi: 10.1016/0022-3468(90)90348-d.
Reference Type
BACKGROUND
Zamir O, Nussbaum MS, Bhadra S, Subbiah MT, Rafferty JF, Fischer JE. Effect of enteral feeding on hepatic steatosis induced by total parenteral nutrition. JPEN J Parenter Enteral Nutr. 1994 Jan-Feb;18(1):20-5. doi: 10.1177/014860719401800120.
Reference Type
BACKGROUND
Kaminski DL, Adams A, Jellinek M. The effect of hyperalimentation on hepatic lipid content and lipogenic enzyme activity in rats and man. Surgery. 1980 Jul;88(1):93-100. No abstract available.
Reference Type
BACKGROUND
Hultin M, Carneheim C, Rosenqvist K, Olivecrona T. Intravenous lipid emulsions: removal mechanisms as compared to chylomicrons. J Lipid Res. 1995 Oct;36(10):2174-84.
Reference Type
BACKGROUND
Qi K, Al-Haideri M, Seo T, Carpentier YA, Deckelbaum RJ. Effects of particle size on blood clearance and tissue uptake of lipid emulsions with different triglyceride compositions. JPEN J Parenter Enteral Nutr. 2003 Jan-Feb;27(1):58-64. doi: 10.1177/014860710302700158.
Reference Type
BACKGROUND
Nestel PJ. Effects of N-3 fatty acids on lipid metabolism. Annu Rev Nutr. 1990;10:149-67. doi: 10.1146/annurev.nu.10.070190.001053. No abstract available.
Reference Type
BACKGROUND
Chen WJ, Yeh SL, Huang PC. Effects of fat emulsions with different fatty acid composition on plasma and hepatic lipids in rats receiving total parenteral nutrition. Clin Nutr. 1996 Feb;15(1):24-8. doi: 10.1016/s0261-5614(96)80257-3.
Reference Type
BACKGROUND
Yeh SL, Chen WJ, Huang PC. Effects of fish oil and safflower oil emulsions on diet-induced hepatic steatosis in rats receiving total parenteral nutrition. Clin Nutr. 1996 Apr;15(2):80-3. doi: 10.1016/s0261-5614(96)80024-0.
Reference Type
BACKGROUND
Kinsella JE, Lokesh B, Broughton S, Whelan J. Dietary polyunsaturated fatty acids and eicosanoids: potential effects on the modulation of inflammatory and immune cells: an overview. Nutrition. 1990 Jan-Feb;6(1):24-44; discussion 59-62. No abstract available.
Reference Type
BACKGROUND
Gura KM, Lee S, Valim C, Zhou J, Kim S, Modi BP, Arsenault DA, Strijbosch RA, Lopes S, Duggan C, Puder M. Safety and efficacy of a fish-oil-based fat emulsion in the treatment of parenteral nutrition-associated liver disease. Pediatrics. 2008 Mar;121(3):e678-86. doi: 10.1542/peds.2007-2248.
Reference Type
BACKGROUND
Strijbosch RA, Lee S, Arsenault DA, Andersson C, Gura KM, Bistrian BR, Puder M. Fish oil prevents essential fatty acid deficiency and enhances growth: clinical and biochemical implications. Metabolism. 2008 May;57(5):698-707. doi: 10.1016/j.metabol.2008.01.008.
Reference Type
BACKGROUND
Gura KM, Calkins KL, Premkumar MH, Puder M. Use of Intravenous Soybean and Fish Oil Emulsions in Pediatric Intestinal Failure-Associated Liver Disease: A Multicenter Integrated Analysis Report on Extrahepatic Adverse Events. J Pediatr. 2022 Feb;241:173-180.e1. doi: 10.1016/j.jpeds.2021.10.030. Epub 2021 Oct 23.
Reference Type
DERIVED
Gura KM, Premkumar MH, Calkins KL, Puder M. Fish Oil Emulsion Reduces Liver Injury and Liver Transplantation in Children with Intestinal Failure-Associated Liver Disease: A Multicenter Integrated Study. J Pediatr. 2021 Mar;230:46-54.e2. doi: 10.1016/j.jpeds.2020.09.068. Epub 2020 Oct 8.
Reference Type
DERIVED
Gura K, Premkumar MH, Calkins KL, Puder M. Intravenous Fish Oil Monotherapy as a Source of Calories and Fatty Acids Promotes Age-Appropriate Growth in Pediatric Patients with Intestinal Failure-Associated Liver Disease. J Pediatr. 2020 Apr;219:98-105.e4. doi: 10.1016/j.jpeds.2019.12.065. Epub 2020 Feb 12.
Reference Type
DERIVED
Premkumar MH, Carter BA, Hawthorne KM, King K, Abrams SA. High rates of resolution of cholestasis in parenteral nutrition-associated liver disease with fish oil-based lipid emulsion monotherapy. J Pediatr. 2013 Apr;162(4):793-798.e1. doi: 10.1016/j.jpeds.2012.10.019. Epub 2012 Nov 16.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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H-23365
Identifier Type: -
Identifier Source: org_study_id
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