| Primary | Number of Participants With Cholestasis | Cholestasis was defined as a direct bilirubin > 2 mg/dL on two measurements 5 to 7 days apart. | All participants who received study lipid or were included as historic controls. | Posted | | Count of Participants | | Participants | | Patients were monitored during time enrolled in study for a maximum of up to 12 weeks or 84 days. | | | | ID | Title | Description |
|---|
| OG000 | Smoflipid 20% | Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. | | OG001 | Intralipid 20% Reduction | Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. | | OG002 | Intralipid 20% Historic | A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded. |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Fisher Exact | | 0.590 | | | | | | | | | | | | | | Superiority | | | | | Fisher Exact | | 0.224 | | |
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| Secondary | Weight Velocity | Weight velocity was calculated as the difference in weight from end to start of study divided by number of days enrolled in study. | All participants included. | Posted | | Mean | Standard Deviation | grams per day | | Patient weight was recorded at enrollment, weekly during time enrolled, and at end of study for up to a maximum of 12 weeks. End and enrollment weights were used to calculate velocity. | | | | ID | Title | Description |
|---|
| OG000 | Smoflipid 20% | Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. | | OG001 | Intralipid 20% Reduction | Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. |
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| Secondary | Length Velocity | Length velocity was defined as the difference in length from end of study compared to enrollment divided by the number of days enrolled in study. | | Posted | | Mean | Standard Deviation | centimeters per day | | Length was measured at enrollment, weekly during time enrolled in study, and end of study up to a maximum of 12 weeks. End and enrollment measurements were used for velocity. | | | | ID | Title | Description |
|---|
| OG000 | Smoflipid 20% | Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. | | OG001 | Intralipid 20% Reduction | Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. |
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| Secondary | Head Circumference (OFC) Velocity | OFC velocity was calculated as difference end and start of study divided by number of days enrolled in study. | | Posted | | Mean | Standard Deviation | centimeters per day | | OFC was measured at enrollment, weekly, and end of study. Enrollment and end of study measurements used for velocity. | | | | ID | Title | Description |
|---|
| OG000 | Smoflipid 20% | Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. | | OG001 | Intralipid 20% Reduction | Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. |
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| Secondary | Average Total Calorie Intake | Total calorie intake, including parenteral and enteral sources, were averaged on a weekly basis. | | Posted | | Mean | Standard Deviation | kcal per kilograms per day | | Daily calorie intake was recorded and averaged on a weekly basis for duration of study enrollment up to max of 12 weeks. | | | | ID | Title | Description |
|---|
| OG000 | Smoflipid 20% | Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. | | OG001 | Intralipid 20% Reduction | Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. |
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| Secondary | Number of Patients With Enteral Autonomy at End of Study | Percentage of patients with enteral autonomy at time of leaving or stopping study was calculated. Enteral autonomy was defined as relying on enteral nutrition only for nutrition intake with no need for parenteral nutrition supplementation. | | Posted | | Count of Participants | | Participants | | Enteral autonomy was recorded at the study end point for each individual patient. This end point was at time of stopping study lipid, discharge from hospital, or maximum of 12 weeks. | | | | ID | Title | Description |
|---|
| OG000 | Smoflipid 20% | Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. | | OG001 | Intralipid 20% Reduction | Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. |
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| Secondary | Number of Patients With Essential Fatty Acid Deficiency (EFAD) | Essential fatty acid deficiency was defined as a triene to tetraene ratio greater than 0.05. | Only prospective participants were included in this analysis as retrospective controls did not have essential fatty acid levels obtained. | Posted | | Count of Participants | | Participants | | Essential fatty acid levels were measured every 4 weeks during enrollment for a maximum of up to 12 weeks. | | | | ID | Title | Description |
|---|
| OG000 | Smoflipid 20% | 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. Lipid Emulsions, Intravenous: Intravenous lipid containing soy, MCT, olive, and fish oils | | OG001 | Intralipid 20% 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. Intralipid, 20% Intravenous Emulsion: Intravenous lipid emulsion of 20% soy oil |
| |
| Secondary | AST Change Over Time | The change of AST over time was calculated and compared between groups. AST change was calculated as AST end - AST enrollment. | | Posted | | Mean | Standard Deviation | units per liter | | AST was recorded at enrollment and every 2 weeks while enrolled in the study up to a maximum of 12 weeks. | | | | ID | Title | Description |
|---|
| OG000 | Smoflipid 20% | Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. | | OG001 | Intralipid 20% Reduction | Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. |
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| Secondary | ALT Change Over Time | The rate of change of ALT over time was compared between groups using mixed model analysis. Change of ALT was calculated as ALT at end of study compared to ALT at enrollment. | | Posted | | Mean | Standard Deviation | units per liter | | ALT measured at enrollment and every 2 weeks for max 12 weeks. | | | | ID | Title | Description |
|---|
| OG000 | Smoflipid 20% | Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. | | OG001 | Intralipid 20% Reduction | Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. |
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| Secondary | Alkaline Phosphatase Change Over Time | Alkaline phosphatase was recorded at enrollment and every 2 weeks. The change in alkaline phosphatase was calculated as alkaline phosphatase at end minus enrollment. | | Posted | | Mean | Standard Deviation | units per liter | | Alkaline phosphatase was measured at enrollment and every 2 weeks for max of 12 weeks. | | | | ID | Title | Description |
|---|
| OG000 | Smoflipid 20% | Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. | | OG001 | Intralipid 20% Reduction | Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. |
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| Secondary | Triglyceride Level Over Time | All enrolled patients had serum triglyceride levels monitored at enrollment and weekly. The triglyceride level changes was calculated using values at the end of study compared to enrollment with mean and standard deviation calculated for each treatment group. | | Posted | | Mean | Standard Deviation | mg/dL | | Serum triglyceride levels monitored at enrollment and weekly during time enrolled in study for a maximum of 12 weeks. | | | | ID | Title | Description |
|---|
| OG000 | Smoflipid 20% | Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. | | OG001 | Intralipid 20% Reduction | Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. |
|
| Secondary | Gamma Glutamyl Transferase (GGT) Over Time | GGT was documented at baseline and regularly intervals with level compared over time between groups. GGT was compared by treatment group for levels at end of study and enrollment. | | Posted | | Mean | Standard Deviation | units per liter | | GGT was measured at enrollment and every 2 weeks while enrolled in the study for a maximum of up to 12 weeks. | | | | ID | Title | Description |
|---|
| OG000 | Smoflipid 20% | Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. | | OG001 | Intralipid 20% Reduction | Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. |
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| Secondary | Number of Patients With Retinopathy of Prematurity | The rate of retinopathy of prematurity (ROP) was compared between groups. ROP was diagnosed based on ophthalmologist examination with all stages included. | | Posted | | Count of Participants | | Participants | | Diagnosis was based on diagnosis during time of initial hospitalization to level 4 NICU. | | | | ID | Title | Description |
|---|
| OG000 | Smoflipid 20% | Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. | | OG001 | Intralipid 20% Reduction | Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. |
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| Secondary | Number of Patients With Bronchopulmonary Dysplasia (BPD) or Chronic Lung Disease | The rate of BPD was documented and compared between groups. BPD was diagnosed based on need for respiratory support at 28 days of age. All levels of severity were included. | | Posted | | Count of Participants | | Participants | | All patient had diagnosis of BPD documented from admission at level 4 NICU. | | | | ID | Title | Description |
|---|
| OG000 | Smoflipid 20% | Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. | | OG001 | Intralipid 20% Reduction | Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. |
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| Secondary | NICU Length of Stay | The length of stay at the level 4 NICU was compared between groups. | | Posted | | Mean | Standard Deviation | days | | Length of stay will be calculated based on documenting each patient's admission date and date leaving the NICU. | | | | ID | Title | Description |
|---|
| OG000 | Smoflipid 20% | Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. | | OG001 | Intralipid 20% Reduction | Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy. |
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| Secondary | Three Year Development- Communication | During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores show improved outcomes. Scores are separated into on schedule, monitoring zone, and below cutoff. These thresholds vary by aged screened. Possible screens used for this age group include 36 months, 42 months, and 48 months dependent on exact chronologic age screen completed. At 36 months communication 45-60 is on schedule; 35-40 monitoring, and <35 below cutoff. For 42 months on schedule 40-60; monitoring 30-35; below cutoff <35. For 48 months on schedule 45-60; monitoring 35-40; below cutoff <35. | Only the prospective patients treated by the research team were included in developmental assessment. The Intralipid 20% Historic group was not included in analysis as these patients were not treated by the research team and developmental screening could not be performed on these patients. Data for the "Intralipid 20% Historic" arm was not collected as specified by the study protocol and statistical analysis plan. | Posted | | Mean | Standard Deviation | score on a scale | | ASQ was completed during the third year of life from 3 years 0 days to 3 years 364 days of chronologic age. | | | | ID | Title | Description |
|---|
| OG000 | Smoflipid 20% | 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. Lipid Emulsions, Intravenous: Intravenous lipid containing soy, MCT, olive, and fish oils |
|
| Secondary | Three Year Development: Gross Motor | During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores indicate improved outcome, there are three possible scoring categories on schedule (normal), monitoring zone, below cutoff. Score thresholds by possible screens include: 36 months on schedule 50-60; monitoring 40-45; below cutoff <40. 42 months on schedule 50-60; monitoring 40-45; below cutoff <40. 48 months on schedule 45-60; monitoring 35-40; below cutoff <35. | Only the prospective patients treated by the research team were included in developmental assessment. The Intralipid 20% Historic group was not included in analysis as these patients were not treated by the research team and developmental screening could not be performed on these patients. Data for the "Intralipid 20% Historic" arm was not collected as specified by the study protocol and statistical analysis plan. | Posted | | Mean | Standard Deviation | score on a scale | | three year chronological age 3 years and 0 days to 3 years and 364 days | | | | ID | Title | Description |
|---|
| OG000 | Smoflipid 20% | 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. Lipid Emulsions, Intravenous: Intravenous lipid containing soy, MCT, olive, and fish oils | | OG001 |
|
| Secondary | Three Year Development: Fine Motor | During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores show improved outcomes with three scoring categories: on schedule (normal), monitoring zone, and below cutoff. These thresholds vary by each category and screening age. Based on the possible screens for chronological age the score categories are: 36 months: 35-60 on schedule; 20-30 monitoring; <20 below cutoff. 42 months: 35-60 on schedule; 20-30 monitoring; <20 below cutoff. 48 months: 35-60 on schedule; 20-30 monitoring; <20 below cutoff. | Only the prospective patients treated by the research team were included in developmental assessment. The Intralipid 20% Historic group was not included in analysis as these patients were not treated by the research team and developmental screening could not be performed on these patients. Data for the "Intralipid 20% Historic" arm was not collected as specified by the study protocol and statistical analysis plan. | Posted | | Mean | Standard Deviation | score on a scale | | three year chronological age (3 years and 0 days to 3 years and 364 days) | | | | ID | Title | Description |
|---|
| OG000 | Smoflipid 20% | 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. Lipid Emulsions, Intravenous: Intravenous lipid containing soy, MCT, olive, and fish oils |
|
| Secondary | Three Year Development: Problem Solving | During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores indicate improved outcomes with three possible score categories: on schedule (normal), monitoring zone, and below cutoff. Category thresholds vary by outcome category and age of screen. There are three possible screens that were used for this population, chosen based on chronologic age. The score categories based on age are: 36 months: 45-60 on schedule; 35-40 monitoring; <35 below cutoff. 42 months: 40-60 on schdule; 30-35 monitoring; <30 below cutoff. 48 months: 45-60 on schedule; 35-40 monitoring; <35 below cutoff | Only the prospective patients treated by the research team were included in developmental assessment. The Intralipid 20% Historic group was not included in analysis as these patients were not treated by the research team and developmental screening could not be performed on these patients. Data for the "Intralipid 20% Historic" arm was not collected as specified by the study protocol and statistical analysis plan. | Posted | | Mean | Standard Deviation | score on a scale | | three year chronological age (3 years and 0 days to 3 years and 364 days) | | | | ID | Title | Description |
|---|
| OG000 | Smoflipid 20% | 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. Lipid Emulsions, Intravenous: Intravenous lipid containing soy, MCT, olive, and fish oils |
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| Secondary | Three Year Development: Personal Social | During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores indicate improved outcomes with three score categories possible including on schedule (normal), monitoring zone, and below cutoff. These thresholds vary based on outcome measure and age of screen completed. Screen used depends on chronological age at screen. Score thresholds for each age include: 36 months: 45-60 on schedule; 35-40 monitoring; <35 below cutoff. 42 months: 45-60 on schedule; 35-40 monitoring; <35 below cutoff. 48 months: 40-60 on schedule; 30-40 monitoring; <30 below cutoff. | Only the prospective patients treated by the research team were included in developmental assessment. The Intralipid 20% Historic group was not included in analysis as these patients were not treated by the research team and developmental screening could not be performed on these patients. Data for the "Intralipid 20% Historic" arm was not collected as specified by the study protocol and statistical analysis plan. | Posted | | Mean | Standard Deviation | score on a scale | | three year chronological age (3 years and 0 days to 3 years and 364 days) | | | | ID | Title | Description |
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| OG000 | Smoflipid 20% | 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. Lipid Emulsions, Intravenous: Intravenous lipid containing soy, MCT, olive, and fish oils |
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