infants subjected to corrective surgery for congenital abnormalities and needing prolonged PN using a new generation intravenous lipid emulsion

infants subjected to corrective surgery for congenital abnormalities and needing prolonged PN using a current intravenous lipid emulsion

Intrahepatic, Cholestasis

Exclusive total parenteral nutrition using a new generation intravenous lipid emulsion composed of 30% LCT n-6 (soybean oil), 30% MCT (coconut oil), 25% monounsaturated fatty acids (olive oil), 15% LCT n-3 (fish oil) and α-tocopherol

SMOFlipid

Exclusive total parenteral nutrition using a current intravenous lipid emulsion composed of 50% LCT (soybean oil) and 50% MCT (coconut oil)

Lipofundin

Reduction of Neonatal Parenteral Nutrition Associated Cholestasis Through Lipid Emulsions

Incidence and Severity of Parenteral Nutrition Associated Cholestasis in Neonates Subjected to Major Surgery, Using Two Mixed Intravenous Lipid Emulsions

Conjugated serum bilirubin >1 mg/dl (34 mmol/L) (Moyer, 2004).

The severity of cholestasis was evaluated by the magnitude of the serum conjugated bilirubin and serum γ-glutamyltranspeptidase (GGT).

Luís Pereira-da-Silva

MD, PhD

Centro Hospitalar de Lisboa Central

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.

In infants who meet the eligibility criteria for Fish Oil Emulsion arm received Fish Oil Emulsion (Omegaven) after enrollment under the study.
Therapy with Fish Oil Emulsion (Omegaven) was provided at a dose of 1 gm/kg/day (by continuous infusion) and was infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. If previously on Intralipid, it was stopped prior to initiation of Fish Oil Emulsion.Fish oil emulsion. Treatment was given for as long as the child needed any TPN. If the infant no longer required any TPN, then the Omegaven was stopped. Omegaven was continued even after resolution of cholestasis, as long as the need for parenteral nutrition persisted.

Fish Oil Emulsion Arm

Age (in days) of the subjects at the time of initiation of Omegaven

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Cholestasis is defined as serum conjugated bilirubin ≥ 2 mg/dL at the time of initiation of Fish Oil Emulsion (Omegaven).

Infants with Cholestasis

Infants who required parenteral nutrition either complete or partial at the time of initiation of Fish Oil Emulsion (Omegaven) due to feeding difficulties.

Need for Parenteral Nutrition

Gestational Age at Birth

Birth weight

Time in days from the initiation of fish oil emulsions (initiation of study) until resolution of cholestasis as defined by serum conjugated bilirubin≤ 2 mg/dL prior to EOS (end of study).

Once eligible, Soybean Oil Emulsion was discontinued and Fish Oil Emulsion was commenced at 1 g/kg/d. Fish Oil Emulsion was provided as an infusion over 18-24 hours a day. Fish Oil Emulsion was provided in a dedicated peripheral or central venous access.

Time to Resolution of Parenteral Nutrition Associated Cholestasis Prior to End of Study

To describe proportion of infants who died secondary to any cause, related or unrelated to Fish Oil Emulsion.

All Cause Mortality During the Study.

The Z-score indicated the number of standard deviations away from the mean. A weight Z-score of 0 is equal to the mean. A weight Z-score of ≤ -2 indicates an underweight status, while a weight Z-score of ≥ 2 indicates overweight or obese status.

Growth Z-scores for Weight

To describe the number of infants who achieved resolution of cholestasis following initiation of fish oil emulsion.

Number of Infants Who Achieve Resolution of Parenteral Nutrition Associated Cholestasis

To describe the number of study subjects who experienced a platelet count below <100,000/µL anytime during the duration of the study.

Number of Subjects With Platelet Count <100,000/µL

To describe the number of study subjects who experienced an INR ≥1.4 anytime during the duration of the study.

Number of Subjects With INR ≥1.4.

To describe the number of study subjects who experienced a bloodstream infection during the duration of the study.
Bloodstream infection as defined by detection by the culture of bacteria or fungus from the blood.

Number of Study Subjects Who Experienced a Blood Stream Infection

To describe the number and percentage of infants who required liver or multi-visceral transplant.

Liver or Multi-visceral Transplant

To describe number and percentage of infants who died secondary to any cause, related or unrelated to Fish Oil Emulsion.

All-cause Mortality up to Hospital Discharge

Overall Study

Dr. Muralidhar H Premkumar

Once eligible, Soybean Oil Emulsion was discontinued and Fish Oil Emulsion was commenced at 1 g/kg/d. Fish Oil Emulsion was provided as an infusion over 18-24 hours a day. Fish Oil Emulsion was provided in a dedicated peripheral or central venous access.
Any cause mortality prior to the End of Study

Cholestasis

Cholestasis of Parenteral Nutrition

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.

Omegaven

Baylor College of Medicine

Texas Children's Hospital

Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants

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

Please see the IPD sharing section below.

Muralidhar Premkumar

Assistant Professor

Boston Children's Hospital

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.

hypertriglyceridemia/phosphatase

Reduction of Neonatal Parenteral Nutrition Associated Cholestasis Through Lipid Emulsions

Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants

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