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The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in late preterm and term neonates with major GI surgical disorders
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose intravenous lipids | Experimental |
| |
| high dose of intravenous lipids | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous lipid | Drug | intravenous given daily for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Parenteral Nutrition Associated Cholestasis | Defined as direct bilirubin ≥ 2mg/dl developing within one week of the completion of 6 week randomization period | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Rate of Change in Direct Bilirubin | Amount of direct (conjugated) bilirubin was measured from sera samples. | baseline, weeks 1, 2, 3, 4, 5 and 6 |
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Inclusion Criteria:
All neonates ≥ 34 weeks gestational age with major GI surgical disorders (Gastroschisis, omphalocele, volvulus, trachea-esophageal fistula, duodenal atresia, jejunal atresia, ileal atresia, hirschsprung's disease, anorectal malformation, intestinal obstruction, and GI perforations) requiring surgery admitted to our NICU within first 72 hours will be eligible for this study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjiv Amin, MD | University of Rochester | Principal Investigator |
| Kunal Gupta, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose Intravenous Lipids | intravenous lipid: intravenous given daily for 6 weeks |
| FG001 | High Dose of Intravenous Lipids | intravenous lipid: intravenous given daily for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose Intravenous Lipids | intravenous lipid: intravenous given daily for 6 weeks |
| BG001 | High Dose of Intravenous Lipids | intravenous lipid: intravenous given daily for 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Parenteral Nutrition Associated Cholestasis | Defined as direct bilirubin ≥ 2mg/dl developing within one week of the completion of 6 week randomization period | Intent to treat analysis | Posted | Count of Participants | Participants | 7 weeks |
|
42 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 | Low Dose Intravenous Lipids | intravenous lipid: intravenous given daily for 6 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholestasis | Hepatobiliary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sanjiv Amin | University of Rochester | 585-273-2696 | sanjiv_amin@urmc.rochester.edu |
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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 | Jan 10, 2019 | Nov 4, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 19, 2018 | Nov 5, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005217 | Fat Emulsions, Intravenous |
| ID | Term |
|---|---|
| D004655 | Emulsions |
| D003102 | Colloids |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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The care taker team provided daily weight to the research pharmacist for calculating the dose of the lipid according to the assignment and then calculated the rate of administration over 18 to 24 hours depending on the volume. The rate and dose was masked to the investigators and participants.
| BG002 | Total | Total of all reporting groups |
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Mean Rate of Change in Direct Bilirubin | Amount of direct (conjugated) bilirubin was measured from sera samples. | Posted | Mean | Inter-Quartile Range | mg/dL/week | baseline, weeks 1, 2, 3, 4, 5 and 6 |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | High Dose of Intravenous Lipids | intravenous lipid: intravenous given daily for 6 weeks | 0 | 20 | 0 | 20 | 0 | 20 |
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| D057947 |
| Parenteral Nutrition Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |