Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01FD005085-01A1 | U.S. FDA Grant/Contract | View source |
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| Name | Class |
|---|---|
| Seattle Children's Hospital | OTHER |
| University of Florida | OTHER |
| Primary Children's Hospital | OTHER |
| University of Colorado, Denver |
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Parenteral nutrition-associated cholestasis (PNAC) and liver disease (PNALD) are associated with significant morbidity and mortality in neonates and is felt to be exacerbated by soybean-based lipid emulsions. Much research is currently being directed at identifying ways to reduce this risk. Reduction of the dose of soybean-based lipid given as a component of parenteral nutrition is one possible strategy. In this study we will compare standard dosing of soybean-based lipid (up to 3/kg/day) with a minimized dose (1 g/kg/day) and evaluate for the development of cholestasis and adequate growth between the two groups. Longterm followup will include an assessment of neurodevelopmental outcomes at 12 and 24 months of age.
Funding source - FDA OOPD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced Lipid | Experimental | Subjects will receive a minimized dose (1 g/kg/day) of the soybean-based lipid component of parenteral nutrition. |
|
| Standard Lipid | Active Comparator | Subjects will receive the standard dose (up to 3 g/kg/day) of the soybean-based lipid component of parenteral nutrition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intralipid 20% I.V. Fat Emulsion | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Rise of Direct Bilirubin as a Function of Time | The rate of rise (change over time) of direct bilirubin was compared between the two groups at different time points. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Meghan A Arnold, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado/Children's Hospital Colorado | Aurora | Colorado | 80045 | United States | ||
| University of Florida |
Patients who were enrolled were randomized shortly after enrollment. 1 patient was removed immediately after enrollment, before intervention, due to a screen fail.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Reduced Lipid | Subjects will receive a minimized dose (1 g/kg/day) of the soybean-based lipid component of parenteral nutrition. Intralipid 20% I.V. Fat Emulsion |
| FG001 | Standard Lipid | Subjects will receive the standard dose (up to 3 g/kg/day) of the soybean-based lipid component of parenteral nutrition. Intralipid 20% I.V. Fat Emulsion |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period |
|
| |||||||||||||||||||||
| Neurodevelopmental Outcome Follow Up |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Reduced Lipid | Subjects will receive a minimized dose (1 g/kg/day) of the soybean-based lipid component of parenteral nutrition. Intralipid 20% I.V. Fat Emulsion |
| BG001 | Standard Lipid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at randomization in TATUM |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Rise of Direct Bilirubin as a Function of Time | The rate of rise (change over time) of direct bilirubin was compared between the two groups at different time points. | Analyzable data was not available for one participant in the Reduced Lipid Arm | Posted | Number | 95% Confidence Interval | mg/dL/day | 12 weeks |
|
Two years
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reduced Lipid | Subjects will receive a minimized dose (1 g/kg/day) of the soybean-based lipid component of parenteral nutrition. Intralipid 20% I.V. Fat Emulsion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Line Complication, Removal, or Replacement | Surgical and medical procedures | Systematic Assessment |
There was a smaller sample size than expected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meghan Arnold | University of Michigan | 734-936-8978 | meghanar@umich.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2018 | Dec 20, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002779 | Cholestasis |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C545823 | soybean oil, phospholipid emulsion |
Not provided
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 12 weeks |
| The Time to Development of PNAC | The time to development was compared between the standard and reduced lipid groups. | 12 weeks |
| The Time to Development of Severe PNAC | The time to development from randomization was compared between the standard and reduced lipid groups. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 2 years |
| Gainesville |
| Florida |
| 32601 |
| United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84132 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| NOT COMPLETED |
|
|
Subjects will receive the standard dose (up to 3 g/kg/day) of the soybean-based lipid component of parenteral nutrition.
Intralipid 20% I.V. Fat Emulsion
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Diagnosis | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Analyzable data was not available for one participant in the Reduced Lipid Arm | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
|
| Secondary | 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. | Analyzable data was not available for one participant in the Reduced Lipid Arm | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
|
| Secondary | The Time to Development of PNAC | The time to development was compared between the standard and reduced lipid groups. | Only the subjects that developed PNAC were analyzed | Posted | Median | Full Range | days | 12 weeks |
|
|
|
|
| Secondary | The Time to Development of Severe PNAC | The time to development from randomization was compared between the standard and reduced lipid groups. | Subjects who developed severe PNAC as defined by a direct bilirubin value of 4 mg/dL or greater | Posted | Number | Days | 12 weeks |
|
|
|
| Secondary | 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. | Subjects with total bilirubin values collected after 1 week | Posted | Median | Full Range | mg/dL | 12 weeks |
|
|
|
| Secondary | 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. | Subjects with direct bilirubin values collected after 1 week | Posted | Median | Full Range | mg/dL | 12 weeks |
|
|
|
| Secondary | The Prevalence of Essential Fatty Acid Deficiency (EFAD) | The number of participants who experienced EFAD was compared between the standard and reduced lipid groups. | All patients in the reduced lipid group were analyzed. The standard lipid group had essential fatty acid profile drawn for one patient as not all patients in the standard group required the essential fatty acid profile to be drawn. | Posted | Count of Participants | Participants | No | 12 weeks |
|
|
|
| Secondary | 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. | All subjects aside from the screen fail. Z-scores were recorded while subjects were "on treatment" which meant that they were recorded until 7 days after parenteral nutrition (PN) had been discontinued, but not to exceed 12 weeks for subjects still on PN. This is why the participants analyzed each week is a different number and decreasing with time | Posted | Median | Full Range | z-score | 12 weeks |
|
|
|
| Secondary | 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. | All subjects aside from the screen fail. Z-scores were recorded while subjects were "on treatment" which meant that they were recorded until 7 days after parenteral nutrition (PN) had been discontinued, but not to exceed 12 weeks for subjects still on PN. This is why the participants analyzed each week is a different number and decreasing with time | Posted | Median | Full Range | z-score | 12 weeks |
|
|
|
| Secondary | 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. | All subjects aside from the screen fail. Z-scores were recorded while subjects were "on treatment" which meant that they were recorded until 7 days after parenteral nutrition (PN) had been discontinued, but not to exceed 12 weeks for subjects still on PN. This is why the participants analyzed each week is a different number and decreasing with time | Posted | Median | Full Range | z-score | 12 weeks |
|
|
|
| Secondary | 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. | Subjects who experienced an episode of suspected sepsis, catheter-related blood stream infection, or NEC | Posted | Number | episodes | 12 weeks |
|
|
|
| Secondary | 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. | Participants who returned for their one year follow up | Posted | Median | Full Range | scores on a scale | 1 year |
|
|
|
| Secondary | 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. | Participants who returned for their 2 year follow-up (Note: subjects who did not do their one year follow up were included) | Posted | Median | Full Range | score on a scale | 2 years |
|
|
|
| Secondary | 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. | Participants who returned for their 2 year follow-up (Note: subjects who did not do their one year follow up were included) | Posted | Median | Full Range | percentile | 2 years |
|
|
|
| Secondary | 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. | Participants who returned for their 2 year follow-up (Note: subjects who did not do their one year follow up were included) | Posted | Median | Full Range | percentile | 2 years |
|
|
|
| Secondary | 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. | Subjects who were evaluated using the GMFCS. | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | 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. | Participants who returned for their 2 year follow-up (Note: subjects who did not do their one year follow up were included) | Posted | Median | Full Range | T-Score | 2 years |
|
|
|
| Secondary | 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. | Participants who returned for their 2 year follow-up (Note: subjects who did not do their one year follow up were included) | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | 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. | Participants who returned for their 2 year follow-up (Note: subjects who did not do their one year follow up were included) | Posted | Count of Participants | Participants | 2 years |
|
|
|
| 1 |
| 12 |
| 5 |
| 12 |
| 8 |
| 12 |
| EG001 | Standard Lipid | Subjects will receive the standard dose (up to 3 g/kg/day) of the soybean-based lipid component of parenteral nutrition. Intralipid 20% I.V. Fat Emulsion | 0 | 9 | 4 | 9 | 4 | 9 |
| PNAC | Hepatobiliary disorders | Systematic Assessment |
|
| Necrotizing enterocolitis | Infections and infestations | Systematic Assessment |
|
| PICC associated DVT | Vascular disorders | Systematic Assessment |
|
| Bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Ischemic Bowel Disease | Gastrointestinal disorders | Systematic Assessment |
|
| Hyponatremia | General disorders | Systematic Assessment |
|
| Acute respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Adrenal Insufficiency | Endocrine disorders | Systematic Assessment |
|
| Anemia- Serious | Blood and lymphatic system disorders | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Intestinal Failure- Short Bowel Syndrome | Gastrointestinal disorders | Systematic Assessment |
|
| Inadequate Weight Gain | General disorders | Systematic Assessment |
|
| Metabolic Acidosis- normal anion gap and bicarbonate loss | General disorders | Systematic Assessment |
|
| Bradycardia with Tachypnea | General disorders | Systematic Assessment |
|
| Hyperglycemia | General disorders | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
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| Hypertension | General disorders | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oral Thrush | Infections and infestations | Systematic Assessment |
|
| Non-severe Anemia | General disorders | Systematic Assessment |
|
| Inadequate weight gain- non-severe | General disorders | Systematic Assessment |
|
| Enteritis | General disorders | Systematic Assessment |
|
Not provided
Not provided
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