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The goal of this research study is to compare the levels of free fatty acids and free bilirubin between two intravenous lipid emulsion products in premature newborns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intralipid | Other |
| |
| Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intralipid, 20% Intravenous Emulsion | Drug | Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate. |
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| Measure | Description | Time Frame |
|---|---|---|
| Free Bilirubin (UB) Serum Levels | first day of infusion at 3 g/kg/day | |
| Free Bilirubin (UB) Serum Levels | second day of infusion at 3 g/kg/day |
| Measure | Description | Time Frame |
|---|---|---|
| Unbound Free Fatty Acid (FFAu) Serum Level | To measure unbound free fatty acid level, a fluorescent probe called Acrylodan-Labeled Intestinal Fatty Acid Binding Protein 2 (ADIFAB2) was used. The ADIFAB2 fluorescent probe is a fatty acid binding protein complexed with a fluorescent group. Once mixed with a sample, the ADIFAB2 fluorescent probe binds all unbound free fatty acid in the sample; therefore, measurement of fluorescence indicates the amount of unbound free fatty acid in the sample. After binding of the ADIFAB2 fluorescent probe to the sample, fluorescence intensities are measured at two wavelengths (550 nanometers and 457 nanometers), and for this outcome measure the R value is reported. The R value is the ratio of the fluorescence intensity at 550 nanometers to the fluorescence intensity at 457 nanometers. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cody Arnold, MD | UT Houston HSC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Texas Houston HSC | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intralipid | Intralipid, 20% Intravenous Emulsion: Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate. |
| FG001 | Soybean Oil Medium-chain Triglycerides Olive Oil Fish Oil (SMOF) Lipid |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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 | Sep 25, 2019 |
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| Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid | Drug | Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate. |
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| first day of infusion at 3 g/kg/day |
| Unbound Free Fatty Acid (FFAu) Serum Level | To measure unbound free fatty acid level, a fluorescent probe called ADIFAB2 was used. The ADIFAB2 fluorescent probe is a fatty acid binding protein complexed with a fluorescent group. Once mixed with a sample, the ADIFAB2 fluorescent probe binds all unbound free fatty acid in the sample; therefore, measurement of fluorescence indicates the amount of unbound free fatty acid in the sample. After binding of the ADIFAB2 fluorescent probe to the sample, fluorescence intensities are measured at two wavelengths (550 nanometers and 457 nanometers), and for this outcome measure the R value is reported. The R value is the ratio of the fluorescence intensity at 550 nanometers to the fluorescence intensity at 457 nanometers. | second day of infusion at 3 g/kg/day |
| Free Fatty Acid (Total) Serum Level | second day of infusion at 3 g/kg/day |
| Number of Participants With Direct Bilirubin >1.8 Milligrams Per Deciliter (mg/dL) | first and/or second days of infusion at 3 g/kg/day |
| Number of Participants With Peak Serum Triglyceride Level >350 mg/dl | first or second days of infusion at 3 g/kg/day |
| Mean Serum Triglyceride Level | first day of infusion at 3 g/kg/day |
| Mean Serum Triglyceride Level | second day of infusion at 3 g/kg/day |
Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid: Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate. |
| Completed One Day of Infusion at 3 g/kg/Day |
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| Completed Two Days of Infusion at 3 g/kg/Day |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intralipid | Intralipid, 20% Intravenous Emulsion: Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate. |
| BG001 | SMOF Lipid | SMOF lipid: Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data was not collected for one participant in the Intralipid arm. Data was not collected for one participant in the SMOF lipid arm. | Mean | Standard Deviation | days |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| 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 | Free Bilirubin (UB) Serum Levels | UB levels were measured in 2/3 of the samples before the pandemic closed the analytic laboratory, and the other 1/3 were assessed post-pandemic 1.5 years later. The UB data are invalid due to an issue associated with the delay, that is, the UB measurement device developed by the bench scientist colleagues was recalibrated in the interim such that the UB results pre vs post recalibration are incomparable. Data were not collected for 1 participant in the Intralipid arm. | Posted | Mean | Standard Deviation | Nanomoles/Liter (nM) | first day of infusion at 3 g/kg/day |
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| Primary | Free Bilirubin (UB) Serum Levels | UB levels were measured in 2/3 of the samples before the pandemic closed the analytic laboratory, and the other 1/3 were assessed post-pandemic 1.5 years later. The UB data are invalid due to an issue associated with the delay, that is, the UB measurement device developed by the bench scientist colleagues was recalibrated in the interim such that the UB results pre vs post recalibration are incomparable. | Posted | Mean | Standard Deviation | Nanomoles/Liter (nM) | second day of infusion at 3 g/kg/day |
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| Secondary | Unbound Free Fatty Acid (FFAu) Serum Level | To measure unbound free fatty acid level, a fluorescent probe called Acrylodan-Labeled Intestinal Fatty Acid Binding Protein 2 (ADIFAB2) was used. The ADIFAB2 fluorescent probe is a fatty acid binding protein complexed with a fluorescent group. Once mixed with a sample, the ADIFAB2 fluorescent probe binds all unbound free fatty acid in the sample; therefore, measurement of fluorescence indicates the amount of unbound free fatty acid in the sample. After binding of the ADIFAB2 fluorescent probe to the sample, fluorescence intensities are measured at two wavelengths (550 nanometers and 457 nanometers), and for this outcome measure the R value is reported. The R value is the ratio of the fluorescence intensity at 550 nanometers to the fluorescence intensity at 457 nanometers. | FFAu levels were measured in 2/3 of the samples before the pandemic closed the analytic laboratory, and the other 1/3 were assessed post-pandemic 1.5 years later. The FFAu data are invalid due to an issue associated with the delay, that is, there was severe sample degradation of the FFAu samples that were measured post-pandemic due to prolonged freezing and refreezing-rethawing. | Posted | Mean | Standard Deviation | ratio value (R) | first day of infusion at 3 g/kg/day |
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| Secondary | Unbound Free Fatty Acid (FFAu) Serum Level | To measure unbound free fatty acid level, a fluorescent probe called ADIFAB2 was used. The ADIFAB2 fluorescent probe is a fatty acid binding protein complexed with a fluorescent group. Once mixed with a sample, the ADIFAB2 fluorescent probe binds all unbound free fatty acid in the sample; therefore, measurement of fluorescence indicates the amount of unbound free fatty acid in the sample. After binding of the ADIFAB2 fluorescent probe to the sample, fluorescence intensities are measured at two wavelengths (550 nanometers and 457 nanometers), and for this outcome measure the R value is reported. The R value is the ratio of the fluorescence intensity at 550 nanometers to the fluorescence intensity at 457 nanometers. | FFAu levels were measured in 2/3 of the samples before the pandemic closed the analytic laboratory, and the other 1/3 were assessed post-pandemic 1.5 years later. The FFAu data are invalid due to an issue associated with the delay, that is, there was severe sample degradation of the FFAu samples that were measured post-pandemic due to prolonged freezing and refreezing-rethawing. | Posted | Mean | Standard Deviation | ratio value (R) | second day of infusion at 3 g/kg/day |
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| Secondary | Free Fatty Acid (Total) Serum Level | Data were not collected for this outcome measure. | Posted | second day of infusion at 3 g/kg/day |
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| Secondary | Number of Participants With Direct Bilirubin >1.8 Milligrams Per Deciliter (mg/dL) | Data are reported for all who had 1 or 2 days of infusion of 3 g/kg/day. | Posted | Count of Participants | Participants | first and/or second days of infusion at 3 g/kg/day |
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| Secondary | Number of Participants With Peak Serum Triglyceride Level >350 mg/dl | Of those who had 1 or 2 days of infusion of 3 g/kg/day, data were not collected for 1 participant in the Intralipid arm, and data were not collected for 2 participants in the SMOF lipid arm. | Posted | Count of Participants | Participants | first or second days of infusion at 3 g/kg/day |
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| Secondary | Mean Serum Triglyceride Level | Of those who had infusion of 3 g/kg/day on the first day, data were not collected for 1 participant in the Intralipid arm, and data were not collected for 2 participants in the SMOF lipid arm. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | first day of infusion at 3 g/kg/day |
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| Secondary | Mean Serum Triglyceride Level | Of those who had infusion of 3 g/kg/day for two days, data were not collected for 14 participants in the Intralipid arm, and data were not collected for 13 participants in the SMOF arm. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | second day of infusion at 3 g/kg/day |
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about 5 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intralipid | Intralipid, 20% Intravenous Emulsion: Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate. | 2 | 33 | 2 | 33 | 0 | 33 |
| EG001 | SMOF Lipid | SMOF lipid: Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate. | 1 | 33 | 1 | 33 | 1 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment |
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| Severe intraventricular hemorrhage (IVH) | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Received vasopressors to treat low blood pressure | Vascular disorders | Systematic Assessment |
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UB and FFAu levels were measured in 2/3 of the samples before the pandemic, and the other 1/3 were assessed post-pandemic 1.5 years later. The UB and FFAu data are invalid due to 2 issues associated with the delay: (1) the UB measurement device was recalibrated in the interim such that the UB results pre vs post recalibration are incomparable and (2) for FFAu, there was severe sample degradation of the samples measured post-pandemic due to prolonged freezing and refreezing-rethawing.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cody Arnold | Stanford University | (650) 723-8772 | codya@stanford.edu |
| Jun 29, 2022 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C545823 | soybean oil, phospholipid emulsion |
| D008055 | Lipids |
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SMOF lipid: Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate.
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