| Primary | Number of Patients With Unbound Bilirubin (UB) Concentration Greater Than 30 Nanomoles Per Liter (Nmol/L) | | Data were not collected for 8 participants in the usual prescribed intralipid (UL regimen) arm because 1 died before sampling began, and 7 did not receive sampling because they never achieved the maximum dose of lipid and therefore did not trigger blood draws to begin. Data were not collected for 4 participants in the reduced prescribed intralipid (RL) regimen arm because 3 died before sampling began, and 1 did not achieve the maximum dose of lipid and therefore, did not trigger blood draws. | Posted | | Count of Participants | | Participants | | within first 14 days of life | | | | ID | Title | Description |
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| OG000 | Usual Prescribed Intralipid (UL) Regimen | usual prescribed intralipid (UL) regimen: Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice | | OG001 | Restricted Prescribed Intralipid (RL) Regimen | restricted prescribed intralipid (RL) regimen: Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice). |
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| Primary | Average Unbound Bilirubin (UB) Concentration | 6 UB measurements will be taken per participant .Average of the 6 readings will be reported | Data were not collected for 8 participants in the usual prescribed intralipid (UL regimen) arm because 1 died before sampling began, and 7 did not receive sampling because they never achieved the maximum dose of lipid and therefore did not trigger blood draws to begin. Data were not collected for 4 participants in the reduced prescribed intralipid (RL) regimen arm because 3 died before sampling began, and 1 did not achieve the maximum dose of lipid and therefore, did not trigger blood draws. | Posted | | Mean | Standard Deviation | nanomolar (nM) | | within first 14 days of life | | | | ID | Title | Description |
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| OG000 | Usual Prescribed Intralipid (UL) Regimen | usual prescribed intralipid (UL) regimen: Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice | | OG001 | Restricted Prescribed Intralipid (RL) Regimen | restricted prescribed intralipid (RL) regimen: Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice). |
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| Primary | Brain Stem Auditory-evoked Response (BAER) V Latency | Brainstem auditory evoked response (BAER) testing is a procedure used to assess the auditory pathways of the brainstem and evaluate hearing ability. Wave latency, measured in milliseconds, is the measure of electric transmission of sound. If the wave latency is prolonged, this means that something is in the way of electric sound wave transmission, such as bilirubin which has an affinity for depositing in a specific area of the brainstem that wave V measures. | Data were not collected from 7 participants in the usual prescribed intralipid (UL regimen) arm who received intervention because 7 infants died in the UL arm before BAER testing was performed at 36 weeks PMA . Data were not collected from 10 participants in the reduced prescribed intralipid (RL) regimen arm because 10 infants died in the UL arm before BAER testing was performed at 36 weeks PMA. | Posted | | Mean | Standard Deviation | milliseconds (ms) | | 38 weeks post menstrual age(PMA) | | | | ID | Title | Description |
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| OG000 | Usual Prescribed Intralipid (UL) Regimen | usual prescribed intralipid (UL) regimen: Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice | | OG001 | Restricted Prescribed Intralipid (RL) Regimen | restricted prescribed intralipid (RL) regimen: Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice). |
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| Secondary | Peak Free Fatty Acid Uptake (FFAU) | | Data were not collected for 9 participants in the usual prescribed intralipid (UL) regimen arm because 1 died before sampling, 7 didn't receive blood draws because they never achieved the maximum dose of lipid, and 1 didn't have enough serum for testing. Data were not collected for 5 participants in the reduced prescribed intralipid (RL) regimen arm because 3 died before sampling, 1 didn't achieve the maximum dose of lipid for blood draws and 1 didn't have enough serum for testing. | Posted | | Mean | Standard Deviation | nanomolar (nM) | | within first 14 days of life | | | | ID | Title | Description |
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| OG000 | Usual Prescribed Intralipid (UL) Regimen | usual prescribed intralipid (UL) regimen: Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice | | OG001 | Restricted Prescribed Intralipid (RL) Regimen | restricted prescribed intralipid (RL) regimen: Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice). |
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| Secondary | Peak UB Concentration | | Data were not collected for 8 participants in the usual prescribed intralipid (UL regimen) arm because 1 died before sampling began, and 7 did not receive sampling because they never achieved the maximum dose of lipid and therefore did not trigger blood draws to begin. Data were not collected for 4 participants in the reduced prescribed intralipid (RL) regimen arm because 3 died before sampling began, and 1 did not achieve the maximum dose of lipid and therefore, did not trigger blood draws. | Posted | | Mean | Standard Deviation | nanomolar (nM) | | within first 14 days of life | | | | ID | Title | Description |
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| OG000 | Usual Prescribed Intralipid (UL) Regimen | usual prescribed intralipid (UL) regimen: Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice | | OG001 | Restricted Prescribed Intralipid (RL) Regimen | restricted prescribed intralipid (RL) regimen: Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice). |
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| Secondary | Total Unbound Free Fatty Acids (FFA) | 6 FFA measurements will be taken for each participant.Average of the 6 readings will be reported | Data were not collected for 8 participants in the usual prescribed intralipid (UL regimen) arm because 1 died before sampling began, and 7 did not receive sampling because they never achieved the maximum dose of lipid and therefore did not trigger blood draws to begin. Data were not collected for 4 participants in the reduced prescribed intralipid (RL) regimen arm because 3 died before sampling began, and 1 did not achieve the maximum dose of lipid and therefore, did not trigger blood draws. | Posted | | Mean | Standard Deviation | nanomolar (nM) | | within first 14 days of life | | | | ID | Title | Description |
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| OG000 | Usual Prescribed Intralipid (UL) Regimen | usual prescribed intralipid (UL) regimen: Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice | | OG001 | Restricted Prescribed Intralipid (RL) Regimen | restricted prescribed intralipid (RL) regimen: Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice). |
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| Secondary | Peak Total Serum Bilirubin | | Data were not collected for 8 participants in the usual prescribed intralipid (UL regimen) arm because 1 died before sampling began, and 7 did not receive sampling because they never achieved the maximum dose of lipid and therefore did not trigger blood draws to begin. Data were not collected for 4 participants in the reduced prescribed intralipid (RL) regimen arm because 3 died before sampling began, and 1 did not achieve the maximum dose of lipid and therefore, did not trigger blood draws. | Posted | | Mean | Standard Deviation | milligrams per decilitre (mg/dL) | | within first 14 days of life | | | | ID | Title | Description |
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| OG000 | Usual Prescribed Intralipid (UL) Regimen | usual prescribed intralipid (UL) regimen: Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice | | OG001 | Restricted Prescribed Intralipid (RL) Regimen | restricted prescribed intralipid (RL) regimen: Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice). |
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| Secondary | Number of Patients With Direct Bilirubin Greater Than 1.5 mg/dL | | Data were not collected for 8 participants in the usual prescribed intralipid (UL regimen) arm because 1 died before sampling began, and 7 did not receive sampling because they never achieved the maximum dose of lipid and therefore did not trigger blood draws to begin. Data were not collected for 4 participants in the reduced prescribed intralipid (RL) regimen arm because 3 died before sampling began, and 1 did not achieve the maximum dose of lipid and therefore, did not trigger blood draws. | Posted | | Count of Participants | | Participants | | Before discharge (discharge is on average 3 months after birth) | | | | ID | Title | Description |
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| OG000 | Usual Prescribed Intralipid (UL) Regimen | usual prescribed intralipid (UL) regimen: Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice | | OG001 | Restricted Prescribed Intralipid (RL) Regimen | restricted prescribed intralipid (RL) regimen: Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice). |
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| Secondary | Amount of Protein Given to Participant in Grams Per Kilograms on Day 14 of Life | Calculated as the mean daily protein intake in grams per kilogram of body weight on Day 14 of life. | Data were not collected for 7 participants in the usual prescribed intralipid (UL) regimen arm because 6 participants passed away and 1 participant only received carbohydrates therefore the 1 participant did not receive proteins at day 14 of life. Data were not collected for 6 participants in the restricted prescribed intralipid (RL) regimen arm because 6 participants passed away. | Posted | | Mean | Standard Deviation | grams per kilograms | | Day 14 of life | | | | ID | Title | Description |
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| OG000 | Usual Prescribed Intralipid (UL) Regimen | usual prescribed intralipid (UL) regimen: Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice | | OG001 | Restricted Prescribed Intralipid (RL) Regimen | restricted prescribed intralipid (RL) regimen: Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice). |
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| Secondary | Amount of Carbohydrates Given to Participant in Grams Per Kilograms on Day 14 of Life | Calculated as the mean daily carbohydrates intake in grams per kilogram of body weight on Day 14 of life. | Data were not collected for 6 participants in the usual prescribed intralipid (UL) regimen arm because 6 participants passed away. Data were not collected for 6 participants in the restricted prescribed intralipid (RL) regimen arm because 6 participants passed away. | Posted | | Mean | Standard Deviation | Grams Per Kilograms | | Day 14 of life | | | | ID | Title | Description |
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| OG000 | Usual Prescribed Intralipid (UL) Regimen | usual prescribed intralipid (UL) regimen: Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice | | OG001 | Restricted Prescribed Intralipid (RL) Regimen | restricted prescribed intralipid (RL) regimen: Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice). |
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| Secondary | Amount of Fats Given to Participant in Grams Per Kilograms on Day 14 of Life | Calculated as the mean daily fats intake in grams per kilogram of body weight on Day 14 of life. | Data were not collected for 7 participants in the usual prescribed intralipid (UL) regimen arm because 6 participants passed away and 1 participant only received carbohydrates therefore the 1 participant did not receive fats on day 14 of life. Data were not collected for 6 participants in the restricted prescribed intralipid (RL) regimen arm because 6 participants passed away. | Posted | | Mean | Standard Deviation | Grams Per Kilograms | | Day 14 of Life | | | | ID | Title | Description |
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| OG000 | Usual Prescribed Intralipid (UL) Regimen | usual prescribed intralipid (UL) regimen: Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice | | OG001 | Restricted Prescribed Intralipid (RL) Regimen | restricted prescribed intralipid (RL) regimen: Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice). |
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| Secondary | Weight z Score | Weight Z-scores were calculated using the PediTools Fenton Growth Curves Calculator (2013 version), based on the Fenton Preterm Growth Charts. The following thresholds were used for interpretation: Z-score ≤ -2: Growth failure (worse outcome) Z-score = 0: Population mean (appropriate outcome) Z-score 0 to <2: Appropriate growth (better outcome) Z-score ≥ 2: Excessive growth (worse outcome) | Data were not collected for 6 participants in the usual prescribed intralipid (UL) regimen arm because 6 participants passed away. Data were not collected for 7 participants in the restricted prescribed intralipid (RL) regimen arm because 7 participants passed away. | Posted | | Mean | Standard Deviation | z-score | | day 28 | | | | ID | Title | Description |
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| OG000 | Usual Prescribed Intralipid (UL) Regimen | usual prescribed intralipid (UL) regimen: Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice | | OG001 | Restricted Prescribed Intralipid (RL) Regimen | restricted prescribed intralipid (RL) regimen: Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice). |
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| Secondary | Weight | | | Posted | | Median | Inter-Quartile Range | grams | | birth | | | | ID | Title | Description |
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| OG000 | Usual Prescribed Intralipid (UL) Regimen | usual prescribed intralipid (UL) regimen: Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice | | OG001 | Restricted Prescribed Intralipid (RL) Regimen | restricted prescribed intralipid (RL) regimen: Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice). |
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| Secondary | Weight | | Data were not collected from 10 participants in the usual prescribed intralipid (UL) regimen arm because 7 participants passed away and 3 were discharged before 36 weeks. Data were not collected from 14 participants in the restricted prescribed intralipid (RL) regimen arm because 10 participants passed away and 4 were discharged before 36 weeks. | Posted | | Mean | Standard Deviation | grams | | 36 weeks postmenstrual age | | | | ID | Title | Description |
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| OG000 | Usual Prescribed Intralipid (UL) Regimen | usual prescribed intralipid (UL) regimen: Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice | | OG001 | Restricted Prescribed Intralipid (RL) Regimen | restricted prescribed intralipid (RL) regimen: Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice). |
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| Secondary | Number of Patients With Bronchopulmonary Dysplasia | | | Posted | | Count of Participants | | Participants | | 36 weeks post menstrual age | | | | ID | Title | Description |
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| OG000 | Usual Prescribed Intralipid (UL) Regimen | usual prescribed intralipid (UL) regimen: Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice | | OG001 | Restricted Prescribed Intralipid (RL) Regimen | restricted prescribed intralipid (RL) regimen: Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice). |
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| Secondary | Number of Patients With Perinatal and Hospital Acquired Sepsis Episodes | | | Posted | | Count of Participants | | Participants | | birth until discharge ( discharge will be about 3 months post birth) | | | | ID | Title | Description |
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| OG000 | Usual Prescribed Intralipid (UL) Regimen | usual prescribed intralipid (UL) regimen: Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice | | OG001 | Restricted Prescribed Intralipid (RL) Regimen | restricted prescribed intralipid (RL) regimen: Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice). |
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| Secondary | Number of Patients Who Died | | | Not Posted | | | | | | 24 months PMA | | Participants | | | | |
| Secondary | Number of Patients With Neurodevelopmental Impairment | | | Not Posted | | | | | | 24 months PMA | | Participants | | | | |
| Secondary | Number of Patients With Hearing Loss | | | Not Posted | | | | | | 24 months PMA | | Participants | | | | |
| Secondary | Number of Patients With Cerebral Palsy | | | Not Posted | | | | | | 24 months PMA | | Participants | | | | |
| Secondary | Serial FiO2 (Fraction of Inspired Oxygen) | | This outcome measure was pre-specified in the protocol; however, no data were collected for this measure. Due to resource limitations, the study team was unable to obtain the required data. Specifically, staffing limitations led to the decision to not collect any data from any participants for this Outcome Measure. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure. | Posted | | | | | | Day 1 of life through day 14 of life | | | | ID | Title | Description |
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| OG000 | Usual Prescribed Intralipid (UL) Regimen | usual prescribed intralipid (UL) regimen: Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice | | OG001 | Restricted Prescribed Intralipid (RL) Regimen | restricted prescribed intralipid (RL) regimen: Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice). |
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| Secondary | Ventilator Setting | | This outcome measure was pre-specified in the protocol; however, no data were collected for this measure. Due to resource limitations, the study team was unable to obtain the required data. Specifically, staffing limitations led to the decision to not collect any data from any participants for this Outcome Measure. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure. | Posted | | | | | | Day 1 of life through day 14 of life | | | | ID | Title | Description |
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| OG000 | Usual Prescribed Intralipid (UL) Regimen | usual prescribed intralipid (UL) regimen: Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice | | OG001 | Restricted Prescribed Intralipid (RL) Regimen | restricted prescribed intralipid (RL) regimen: Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice). |
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