Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates

Cholestasis was defined as a direct bilirubin \> 2 mg/dL on two measurements 5 to 7 days apart.

Time frame: Patients were monitored during time enrolled in study for a maximum of up to 12 weeks or 84 days.

Population: All participants who received study lipid or were included as historic controls.

Alkaline phosphatase was recorded at enrollment and every 2 weeks. The change in alkaline phosphatase was calculated as alkaline phosphatase at end minus enrollment.

Time frame: Alkaline phosphatase was measured at enrollment and every 2 weeks for max of 12 weeks.

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.

Time frame: ALT measured at enrollment and every 2 weeks for max 12 weeks.

The change of AST over time was calculated and compared between groups. AST change was calculated as AST end - AST enrollment.

Time frame: AST was recorded at enrollment and every 2 weeks while enrolled in the study up to a maximum of 12 weeks.

Total calorie intake, including parenteral and enteral sources, were averaged on a weekly basis.

Time frame: Daily calorie intake was recorded and averaged on a weekly basis for duration of study enrollment up to max of 12 weeks.

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.

Time frame: GGT was measured at enrollment and every 2 weeks while enrolled in the study for a maximum of up to 12 weeks.

OFC velocity was calculated as difference end and start of study divided by number of days enrolled in study.

Time frame: OFC was measured at enrollment, weekly, and end of study. Enrollment and end of study measurements used for 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.

Time frame: 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.

The length of stay at the level 4 NICU was compared between groups.

Time frame: Length of stay will be calculated based on documenting each patient's admission date and date leaving the NICU.

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.

Time frame: All patient had diagnosis of BPD documented from admission at level 4 NICU.

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.

Time frame: 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.

Essential fatty acid deficiency was defined as a triene to tetraene ratio greater than 0.05.

Time frame: Essential fatty acid levels were measured every 4 weeks during enrollment for a maximum of up to 12 weeks.

Population: Only prospective participants were included in this analysis as retrospective controls did not have essential fatty acid levels obtained.

The rate of retinopathy of prematurity (ROP) was compared between groups. ROP was diagnosed based on ophthalmologist examination with all stages included.

Time frame: Diagnosis was based on diagnosis during time of initial hospitalization to level 4 NICU.

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.

Time frame: ASQ was completed during the third year of life from 3 years 0 days to 3 years 364 days of chronologic age.

Population: 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.

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.

Time frame: three year chronological age (3 years and 0 days to 3 years and 364 days)

Population: 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.

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.

Time frame: three year chronological age 3 years and 0 days to 3 years and 364 days

Population: 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.

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.

Time frame: three year chronological age (3 years and 0 days to 3 years and 364 days)

Population: 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.

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

Time frame: three year chronological age (3 years and 0 days to 3 years and 364 days)

Population: 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.

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.

Time frame: Serum triglyceride levels monitored at enrollment and weekly during time enrolled in study for a maximum of 12 weeks.

Weight velocity was calculated as the difference in weight from end to start of study divided by number of days enrolled in study.

Time frame: 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.

Population: All participants included.