Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration

6 UB measurements will be taken per participant .Average of the 6 readings will be reported

Time frame: within first 14 days of life

Population: 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.

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.

Time frame: 38 weeks post menstrual age(PMA)

Population: 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.

Time frame: within first 14 days of life

Population: 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.

Calculated as the mean daily carbohydrates intake in grams per kilogram of body weight on Day 14 of life.

Time frame: Day 14 of life

Population: 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.

Calculated as the mean daily fats intake in grams per kilogram of body weight on Day 14 of life.

Time frame: Day 14 of Life

Population: 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.

Calculated as the mean daily protein intake in grams per kilogram of body weight on Day 14 of life.

Time frame: Day 14 of life

Population: 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.

Time frame: 24 months PMA

Time frame: 36 weeks post menstrual age

Time frame: 24 months PMA

Time frame: Before discharge (discharge is on average 3 months after birth)

Population: 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.

Time frame: 24 months PMA

Time frame: 24 months PMA

Time frame: birth until discharge ( discharge will be about 3 months post birth)

Time frame: within first 14 days of life

Population: 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.

Time frame: within first 14 days of life

Population: 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.

Time frame: within first 14 days of life

Population: 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.

Time frame: Day 1 of life through day 14 of life

Population: 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.

6 FFA measurements will be taken for each participant.Average of the 6 readings will be reported

Time frame: within first 14 days of life

Population: 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.

Time frame: Day 1 of life through day 14 of life

Population: 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.

Time frame: 36 weeks postmenstrual age

Population: 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.

Time frame: birth

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)

Time frame: day 28

Population: 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.