Trial Outcomes & Findings for Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration (NCT NCT04584983)

Results Overview

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

134 participants

Primary outcome timeframe

within first 14 days of life

Results posted on

2025-11-28

Participant Flow

Participant milestones

Participant milestones
Measure	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	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).
Overall Study STARTED	67	67
Overall Study Received Intervention	65	67
Overall Study COMPLETED	65	67
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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).
Overall Study Parental request for withdraw	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Prescribed Intralipid (UL) Regimen n=65 Participants 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	Restricted Prescribed Intralipid (RL) Regimen n=67 Participants 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).	Total n=132 Participants Total of all reporting groups
Age, Customized < 27 weeks gestational age	62 Participants n=30 Participants	64 Participants n=30 Participants	126 Participants n=60 Participants
Age, Customized ≥ 27 weeks gestational age	3 Participants n=30 Participants	3 Participants n=30 Participants	6 Participants n=60 Participants
Sex: Female, Male Female	29 Participants n=30 Participants	34 Participants n=30 Participants	63 Participants n=60 Participants
Sex: Female, Male Male	36 Participants n=30 Participants	33 Participants n=30 Participants	69 Participants n=60 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=30 Participants	22 Participants n=30 Participants	45 Participants n=60 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=30 Participants	37 Participants n=30 Participants	77 Participants n=60 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=30 Participants	8 Participants n=30 Participants	10 Participants n=60 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Asian	1 Participants n=30 Participants	1 Participants n=30 Participants	2 Participants n=60 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Black or African American	25 Participants n=30 Participants	20 Participants n=30 Participants	45 Participants n=60 Participants
Race (NIH/OMB) White	35 Participants n=30 Participants	37 Participants n=30 Participants	72 Participants n=60 Participants
Race (NIH/OMB) More than one race	2 Participants n=30 Participants	0 Participants n=30 Participants	2 Participants n=60 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=30 Participants	9 Participants n=30 Participants	11 Participants n=60 Participants
Region of Enrollment United States	65 participants n=30 Participants	67 participants n=30 Participants	132 participants n=60 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Prescribed Intralipid (UL) Regimen n=57 Participants 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	Restricted Prescribed Intralipid (RL) Regimen n=63 Participants 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).
Number of Patients With Unbound Bilirubin (UB) Concentration Greater Than 30 Nanomoles Per Liter (Nmol/L)	2 Participants	3 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Usual Prescribed Intralipid (UL) Regimen n=57 Participants 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	Restricted Prescribed Intralipid (RL) Regimen n=63 Participants 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).
Average Unbound Bilirubin (UB) Concentration	12.3 nanomolar (nM) Standard Deviation 7.8	13.2 nanomolar (nM) Standard Deviation 7.8

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Usual Prescribed Intralipid (UL) Regimen n=58 Participants 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	Restricted Prescribed Intralipid (RL) Regimen n=57 Participants 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).
Brain Stem Auditory-evoked Response (BAER) V Latency	7.25 milliseconds (ms) Standard Deviation 0.58	7.34 milliseconds (ms) Standard Deviation 0.48

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Prescribed Intralipid (UL) Regimen n=56 Participants 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	Restricted Prescribed Intralipid (RL) Regimen n=62 Participants 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).
Peak Free Fatty Acid Uptake (FFAU)	105.53 nanomolar (nM) Standard Deviation 92.76	64.39 nanomolar (nM) Standard Deviation 81.84

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Prescribed Intralipid (UL) Regimen n=57 Participants 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	Restricted Prescribed Intralipid (RL) Regimen n=63 Participants 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).
Peak UB Concentration	23.4 nanomolar (nM) Standard Deviation 17.5	22.0 nanomolar (nM) Standard Deviation 17.7

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Usual Prescribed Intralipid (UL) Regimen n=57 Participants 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	Restricted Prescribed Intralipid (RL) Regimen n=63 Participants 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).
Total Unbound Free Fatty Acids (FFA)	41.4 nanomolar (nM) Standard Deviation 27.6	31.0 nanomolar (nM) Standard Deviation 34.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Prescribed Intralipid (UL) Regimen n=57 Participants 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	Restricted Prescribed Intralipid (RL) Regimen n=63 Participants 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).
Peak Total Serum Bilirubin	5 milligrams per decilitre (mg/dL) Standard Deviation 1.8	5.2 milligrams per decilitre (mg/dL) Standard Deviation 1.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Prescribed Intralipid (UL) Regimen n=57 Participants 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	Restricted Prescribed Intralipid (RL) Regimen n=63 Participants 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).
Number of Patients With Direct Bilirubin Greater Than 1.5 mg/dL	9 Participants	10 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Usual Prescribed Intralipid (UL) Regimen n=58 Participants 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	Restricted Prescribed Intralipid (RL) Regimen n=61 Participants 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).
Amount of Protein Given to Participant in Grams Per Kilograms on Day 14 of Life	3.62 grams per kilograms Standard Deviation 0.56	3.60 grams per kilograms Standard Deviation 0.48

SECONDARY outcome

Timeframe: 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 carbohydrates intake in grams per kilogram of body weight on Day 14 of life.

Outcome measures

Outcome measures
Measure	Usual Prescribed Intralipid (UL) Regimen n=59 Participants 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	Restricted Prescribed Intralipid (RL) Regimen n=61 Participants 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).
Amount of Carbohydrates Given to Participant in Grams Per Kilograms on Day 14 of Life	13.46 Grams Per Kilograms Standard Deviation 3.53	13.50 Grams Per Kilograms Standard Deviation 2.74

SECONDARY outcome

Timeframe: 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 fats intake in grams per kilogram of body weight on Day 14 of life.

Outcome measures

Outcome measures
Measure	Usual Prescribed Intralipid (UL) Regimen n=58 Participants 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	Restricted Prescribed Intralipid (RL) Regimen n=61 Participants 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).
Amount of Fats Given to Participant in Grams Per Kilograms on Day 14 of Life	4.05 Grams Per Kilograms Standard Deviation 1.39	3.74 Grams Per Kilograms Standard Deviation 1.68

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Usual Prescribed Intralipid (UL) Regimen n=59 Participants 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	Restricted Prescribed Intralipid (RL) Regimen n=60 Participants 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).
Weight z Score	-1.019 z-score Standard Deviation 0.87	-0.870 z-score Standard Deviation 0.72

SECONDARY outcome

Timeframe: birth

Outcome measures

Outcome measures
Measure	Usual Prescribed Intralipid (UL) Regimen n=65 Participants 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	Restricted Prescribed Intralipid (RL) Regimen n=67 Participants 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).
Weight	680 grams Interval 570.0 to 840.0	700 grams Interval 610.0 to 838.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Prescribed Intralipid (UL) Regimen n=55 Participants 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	Restricted Prescribed Intralipid (RL) Regimen n=53 Participants 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).
Weight	1995 grams Standard Deviation 383	2077 grams Standard Deviation 300

SECONDARY outcome

Timeframe: 36 weeks post menstrual age

Outcome measures

Outcome measures
Measure	Usual Prescribed Intralipid (UL) Regimen n=65 Participants 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	Restricted Prescribed Intralipid (RL) Regimen n=67 Participants 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).
Number of Patients With Bronchopulmonary Dysplasia	48 Participants	55 Participants

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Usual Prescribed Intralipid (UL) Regimen n=65 Participants 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	Restricted Prescribed Intralipid (RL) Regimen n=67 Participants 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).
Number of Patients With Perinatal and Hospital Acquired Sepsis Episodes	22 Participants	16 Participants

SECONDARY outcome

Timeframe: 24 months PMA

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months PMA

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months PMA

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months PMA

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Usual Prescribed Intralipid (UL) Regimen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 7 deaths

Restricted Prescribed Intralipid (RL) Regimen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lindsay F Holzapfel, MD, MS

The University of Texas Health Science Center at Houston

Phone: 713-500-6422

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place