Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD

Prevalence of Parenteral Nutrition-associated Cholestasis (PNAC) (Direct Bilirubin ≥2 mg/dL)

The number of participants who had a direct bilirubin ≥2 mg/dL were compared between the standard and reduced lipid groups. Bilirubin data was collected from baseline until 7 days after PN has been discontinued, but not to exceed a total of 12 weeks.

Time frame: 12 weeks

Prevalence of Severe Parenteral Nutrition-associated Cholestasis (PNAC) (Direct Bilirubin ≥4 mg/dL in Subjects on Parenteral Nutrition for at Least 2 Weeks)

The number of participants with severe PNAC defined as a direct bilirubin ≥4 mg/dL were compared between the standard and reduced lipid groups. Bilirubin data was collected from baseline until 7 days after PN has been discontinued, but not to exceed a total of 12 weeks.

Time frame: 12 weeks

The Time to Development of PNAC

The time to development was compared between the standard and reduced lipid groups.

Time frame: 12 weeks

The Time to Development of Severe PNAC

The time to development from randomization was compared between the standard and reduced lipid groups.

Time frame: 12 weeks

Peak Total Bilirubin Level

The peak (highest) total bilirubin collected from each subject from after week 1 to end of treatment. This was compared between the standard and reduced lipid groups.

Time frame: 12 weeks

Peak Direct Bilirubin Level

The peak (highest) direct bilirubin collected from each subject from after week 1 to end of treatment. This was compared between the standard and reduced lipid groups.

Time frame: 12 weeks

The Prevalence of Essential Fatty Acid Deficiency (EFAD)

The number of participants who experienced EFAD was compared between the standard and reduced lipid groups.

Time frame: 12 weeks

Adequacy of Growth as Evaluated by Z-scores for Weight

Z-scores were compared between subjects in the two treatment groups by week. Z-scores are the number of standard deviations above (positive value) or below (negative value) the median on the FENTON and WHO growth charts. Fenton scores were used for infants born \<37 weeks gestation. WHO scores were used for infants born at ≥37 weeks gestation.

Time frame: 12 weeks

Adequacy of Growth as Evaluated by Z-scores for Height

Z-scores were compared between subjects in the two treatment groups. Z-scores are the number of standard deviations above (positive value) or below (negative value) the median on the FENTON and WHO growth charts. Fenton scores were used for infants born \<37 weeks gestation. WHO scores were used for infants born at ≥37 weeks gestation.

Time frame: 12 weeks

Adequacy of Growth as Evaluated by Z-scores for Head Circumference

Z-scores were compared between subjects in the two treatment groups. Z-scores are the number of standard deviations above (positive value) or below (negative value) the median on the FENTON and WHO growth charts. Fenton scores were used for infants born \<37 weeks gestation. WHO scores were used for infants born at ≥37 weeks gestation.

Time frame: 12 weeks

Adverse Events, as Defined by Any Episode of Sepsis and Catheter-related Blood Stream Infections

The number of episodes were compared between the standard and reduced lipid groups of suspected sepsis episodes, NEC, or catheter-related blood stream infections.

Time frame: 12 weeks

Bayley Scales for Infant and Toddler Development (BSID-III) at One Year

The Bayley Scales of Infant and Toddler Development (BSID-III) is designed to assess developmental functioning of infants and toddlers, ages 1 month to 42 months. The instrument includes five distinct scales, of which three scales and associated subscales are utilized for the purposes of this study: cognitive, language (receptive and expressive communication) and motor (fine motor and gross motor). Raw scores are converted to scaled scores using age-standardized norm. The cognitive scaled scores range from 1-19. 1 is a low score and 19 is a high score. The Language scaled scores are calculated by adding the Receptive Communication scores ranging from 1-19 and the Expressive communication scores ranging from 1-19 to give the Language Scaled score of 2-38. The Motor scaled scores are calculated by adding the Fine Motor scores ranging from 1-19 and the Gross Motor scores ranging from 1-19 to give the Motor scaled ranging from 2-38. Higher scores are better than lower scores.

Time frame: 1 year

Bayley Scales for Infant and Toddler Development (BSID-III) at Two Years

The Bayley Scales of Infant and Toddler Development (BSID-III) is designed to assess developmental functioning of infants and toddlers, ages 1 month to 42 months. The instrument includes five distinct scales, of which three scales and associated subscales are utilized for the purposes of this study: cognitive, language (receptive and expressive communication) and motor (fine motor and gross motor). Raw scores are converted to scaled scores using age-standardized norm. The cognitive scaled scores range from 1-19. 1 is a low score and 19 is a high score. The Language scaled scores are calculated by adding the Receptive Communication scores ranging from 1-19 and the Expressive communication scores ranging from 1-19 to give the Language Scaled score of 2-38. The Motor scaled scores are calculated by adding the Fine Motor scores ranging from 1-19 and the Gross Motor scores ranging from 1-19 to give the Motor scaled ranging from 2-38. Higher scores are better than lower scores.

Time frame: 2 years

MacArthur-Bates Communicative Development Inventories (CDI)

The MacArthur-Bates Communicative Development Inventories (CDI) are parent report instruments which capture information about children's developing abilities in early language. Scores are reported as percentiles compared to age-standardized norms. Higher scores are better than lower scores.

Time frame: 2 years

Brief Infant Toddler Social Emotional Assessment (BITSEA) Part 1 of 2

Dichotomous scores are generated based on cut-off scores, which identify subjects to be at risk. The problem scale measures behaviors of the child that if present, represent a problem. The competence scale measures behaviors of the child that if absent, represent a problem. BITSEA percentile rankings are determined from a table that has a limited range and are adjusted for age and sex. A high problem score leads to a low problem percentile. A high competence score leads to a high competence percentile. Percentile rankings for both problem and competence scores range from "4% or less" to "26% or higher". 4 is the lowest percentile score and 26 is the highest percentile score. The 25th percentile is the lower limit of the average range. Higher percentile scores are better than lower percentile scores in both problem and competence categories.

Time frame: 2 years

Gross Motor Function Classification System (GMFCS)

This classification is based on observation with a scale of 1-5. A lower number classification is better than a higher classification, with 1 being the best.

Time frame: 2 years

Behavioral Assessment System for Children-Third Edition (BASC3) Part 1 of 2

The Behavioral Assessment System for Children-Third Edition is a comprehensive set of forms that helps to understand the behaviors and emotions of children. Scores are reported as T-Scores. T-Scores range from 0-120. In a normative population, the mean of standard scores is 50, and standard deviation is 10. For Externalizing Problems T-Score, Internalizing Problems T-Score, Behavioral Symptoms Index T-Score, Clinical Probability Index T-Score, and Functional Impairment Index T-Score lower scores are better than higher scores. For these categories, higher scores are more problematic with scores between 60-70 regarded as "at risk" and scores 70 and above regarded as clinically significant and requiring further assessment and possible treatment. For Adaptive Skills T-Score, a higher score is better than a lower score. For Adaptive Skills T-Score, lower scores are more problematic with scores between 30-40 regarded as "at risk" and scores at or below 30 regarded as clinically significant.

Time frame: 2 years

Behavioral Assessment System for Children-Third Edition (BASC3) Part 2 of 2

The Behavioral Assessment System for Children-Third Edition is a comprehensive set of forms that helps to understand the behaviors and emotions of children. For Overall Executive Functioning Index, Attentional Control Index, Behavioral Control Index, and Emotional Control Index, scores are "Not Elevated" or "Elevated". Not Elevated is better than Elevated.

Time frame: 2 years

Brief Infant Toddler Social Emotional Assessment (BITSEA) Part 2 of 2

Dichotomous scores are generated based on cut-off scores, which identify subjects to be at risk. The problem scale measures behaviors of the child that if present, represent a problem. The competence scale measures behaviors of the child that if absent, represent a problem.

Time frame: 2 years