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| Name | Class |
|---|---|
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
| Northwestern University | OTHER |
| Mead Johnson Nutrition | INDUSTRY |
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The purpose of this study is to determine if buccal administration of a concentrated formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain docosahexaenoic acid (DHA) levels in extremely low birth weight (ELBW) infants.
This will be a multi-center, randomized, placebo controlled, double blind trial.
Two doses of PUFA will be compared to placebo- a "high" dose and a "low" dose.
ELBW infants will be enrolled into this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "high" dose LCPUFA | Experimental | the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants. |
|
| "low" dose LCPUFA | Experimental | the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants. |
|
| placebo | Placebo Comparator | the "placebo" is a drop that will be administered to ELBW infants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCPUFA supplement | Dietary Supplement |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels | LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants | 2 weeks of life |
| Measure | Description | Time Frame |
|---|---|---|
| LCPUFA Levels | LCPUFA levels will be measured at 8 weeks of life. | 8 weeks of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael S Caplan, MD | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States | ||
| Prentice Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27356083 | Derived | Robinson DT, Caplan M, Carlson SE, Yoder R, Murthy K, Frost B. Early docosahexaenoic and arachidonic acid supplementation in extremely-low-birth-weight infants. Pediatr Res. 2016 Oct;80(4):505-10. doi: 10.1038/pr.2016.118. Epub 2016 Jun 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | "High" Dose LCPUFA | the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement |
| FG001 | "Low" Dose LCPUFA | the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement |
| FG002 | Placebo | the "placebo" is a drop that will be administered to ELBW infants. placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | "High" Dose LCPUFA | the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement |
| BG001 | "Low" Dose LCPUFA | the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels | LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants | 2 subjects died prior to having 2 week levels drawn, from causes unrelated to study. | Posted | Median | Inter-Quartile Range | weight % (g/100g) | 2 weeks of life |
|
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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 | "High" Dose LCPUFA | the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | Gastrointestinal disorders | Baby died from NEC, deemed unrelated to study substance |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brandy L Frost | NorthShore University HealthSystem | 847-570-2033 | bfrost@northshore.org |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| placebo |
| Dietary Supplement |
|
| Chicago |
| Illinois |
| 60611 |
| United States |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
| BG002 | Placebo | the "placebo" is a drop that will be administered to ELBW infants. placebo |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Placebo | the "placebo" is a drop that will be administered to ELBW infants. placebo |
|
|
| Secondary | LCPUFA Levels | LCPUFA levels will be measured at 8 weeks of life. | 2 subjects died prior to having 8 week levels drawn, from causes unrelated to study. | Posted | Median | Inter-Quartile Range | wt% (g/100g) | 8 weeks of life |
|
|
|
|
| 1 |
| 10 |
| 0 |
| 10 |
| EG001 | "Low" Dose LCPUFA | the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement | 1 | 10 | 0 | 10 |
| EG002 | Placebo | the "placebo" is a drop that will be administered to ELBW infants. placebo | 0 | 10 | 0 | 10 |
| death | Respiratory, thoracic and mediastinal disorders | severe respiratory failure |
|
| spontaneous bowel perforation | Gastrointestinal disorders |
|
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| D000091642 | Urogenital Diseases |
|