Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates
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|ClinicalTrials.gov Identifier: NCT03387579|
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : February 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cholestasis of Parenteral Nutrition||Drug: Lipid Emulsions, Intravenous Drug: Intralipid, 20% Intravenous Emulsion||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be randomized to one of the two treatment arms, either composite lipid (Smoflipid) or soy-based lipid reduction.|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Composite Lipid Emulsion Containing Fish Oil to Soy-based Lipid Reduction for Cholestasis Prevention in Neonates Requiring Abdominal Surgery|
|Actual Study Start Date :||November 30, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2022|
Active Comparator: Composite fish oil lipid (Smoflipid)
Patients randomized to this arm will receive the composite fish oil lipid, Smoflipid, at standard dosing up to 3 g/kg/day. Patients will be started on a dose of 1 g/kg/day and titrated up to maximum dose. As enteral nutrition is advanced the lipid dose will be weaned per study protocol and dietary recommendations.
Drug: Lipid Emulsions, Intravenous
Intravenous lipid containing soy, MCT, olive, and fish oils
Other Name: Smoflipid
Active Comparator: Soy-based lipid reduction
Patients randomized to this arm will receive soy-based lipid (Intralipid) at a dose of 1 g/kg/day throughout their enrollment in the study.
Drug: Intralipid, 20% Intravenous Emulsion
Intravenous lipid emulsion of 20% soy oil
- Cholestasis [ Time Frame: During enrollment in study, up to maximum of 12 weeks or 84 days ]Direct bilirubin > 2 mg/dL on two measurements 5 to 7 days apart.
- Growth velocity [ Time Frame: Patients weight will be measured on a daily basis while they are randomized in the study. Their weight will be recorded into the study documentation on a weekly basis up to a maximum of 12 weeks or 84 days. ]Change in weight as measured by grams over time
- Growth velocity [ Time Frame: Length will be measured and recorded in the study documentation on a weekly basis up to a maximum of 12 weeks. ]Change in length as measured by centimeters over time
- Growth velocity [ Time Frame: Head circumference will be measured and recorded in the study documentation on a weekly basis up to a maximum of 12 weeks. ]Change in head circumference as measured in centimeters over time
- Maximum total calories from enteral intake [ Time Frame: Total daily calories will be calculated for each patient for the entire time enrolled in the study, or a maximum of 12 weeks. ]Maximum daily caloric intake from enteral intake as calculated by percentage of daily caloric intake.
- Essential fatty acid deficiency [ Time Frame: Patients will have essential fatty acid panels obtained at minimum every four weeks while enrolled in the study up to a maximum of 12 weeks. ]Triene: tetraene ratio > 0.05
- Difference in liver enzymes [ Time Frame: Hepatic function panel and GGT will be obtained every 2 weeks while enrolled up to a maximum of 12 weeks. ]Patients will have transaminase (AST, ALT), alkaline phosphatase, and gamma glutamyl transferase obtained every 2 weeks while enrolled in the study. These values will be recorded for each patient and the differences compared between the two groups.
- Complications of prematurity [ Time Frame: Diagnoses will be documented for entirety of hospitalization, from randomization and enrollment until discharge from the hospital, up to a maximum of 12 months of age. ]Each patient will have their comorbid diagnoses documented with specific interest to retinopathy of prematurity and chronic lung disease or bronchopulmonary dysplasia.
- Triglyceride concentration [ Time Frame: Triglyceride level will be obtained at a minimum of every one week for the entire enrollment of the study up to a maximum of 12 weeks. ]All enrolled patients will have triglyceride levels monitored weekly. If levels are found to be >250 mg/dL in any patient, their lipid dose will be decreased.
- Length of stay [ Time Frame: Length of stay will be calculated based on documenting each patient's admission date, date leaving NICU, and date discharged from the hospital and calculating length of time between each date. An estimated maximum length of time would be 12 months. ]The length of stay, including time in Neonatal Intensive Care Unit (NICU) and entire hospitalization will be documented for each patient.
- Two year development [ Time Frame: ASQ will be completed anytime during the second year of life from 2 years 0 days to 2 years 364 days of chronologic age. ]At two years of chronologic age ASQ will be completed by family.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387579
|Contact: Charles Vanderpool, MDemail@example.com|
|Contact: Katie Huff, MDfirstname.lastname@example.org|
|United States, Indiana|
|Riley Hospital for Children at IU Health||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Charles Vanderpool, MD|