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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD108646 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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A comprehensive analysis of the impact of exogenous enteral DHA and ARA supplementation on lipid metabolism including the production of downstream derived mediators and how this impacts important biological pathways such as metabolism, inflammation, and organogenic factors.
Infants will be randomized to receive the combined enteral DHA/ARA supplement within the first 48 hours after birth to 36 weeks postmenstrual age. The randomization procedure will follow a stratified permuted block scheme to fulfill two goals: (1) randomize infants into one of four arms and (2) ensure an adequate sample size within each week of gestational age. Preterm infants will be randomized using random permuted blocks within each of the 5 birth gestational age strata. When treatment assignment is open and sample size is not overtly large, a block randomization procedure with randomly chosen block sizes can maintain treatment assignment balance and reduce the potential for selection bias. This approach will also ensure that preterm infants of all eligible gestational ages at birth are approximately equally represented in each of 4 arms of the trial, thus ensuring that important comorbidities and standard of care applicable to infants of different gestational ages at birth are also approximately equally distributed across the study arms. There is no placebo for this study. There is no blinding in this study. Consent will also be obtained from the mother of the infant, as they will be asked to provide milk samples if they're breastfeeding their infant, and maternal medical history and demographical data will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DHA/ARA supplement | Other | DHA/ARA supplement throughout the duration of the protocol, "d-on" |
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| No DHA/ARA supplement | No Intervention | no DHA/ARA supplement throughout the duration of the protocol, "d-off" | |
| DHA/ARA initially then no supplement | Other | DHA/ARA supplement from enrollment to 31 6/7 weeks post-menstrual age (PMA) then no supplement from 32 to 36 weeks' PMA, "x- on/off" |
|
| No supplement initially then DHA/ARA supplement | Other | No DHA/ARA supplement till 31 6/7 weeks' then long-chain polyunsaturated fatty acids (LCPUFA) supplement from 32 to 36 weeks PMA, "x-off/on" |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enfamil® DHA & ARA Supplement for Special Dietary Use | Dietary Supplement | Dosage: 60 mg/kg/day of DHA and 120 mg/kg/day of ARA. Route of administration: enteral tube or by oral syringe |
| Measure | Description | Time Frame |
|---|---|---|
| Fatty acid levels in plasma | Change in lipid metabolites reflected by levels in plasma | Baseline to 36 weeks |
| Fatty acid levels in red blood cell (RBC) membranes | Change in fatty acid levels in RBC membranes | Baseline to 36 weeks |
| Change in circulating biomarker Lipoxin A4 | Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates. | Baseline to 36 weeks |
| Change in biomarker Resolvin D1 | Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates. | Baseline to 36 weeks |
| Change in biomarker Resolvin E1 | Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates. | Baseline to 36 weeks |
| Change in Protectin/Neuroprotectin | Levels of protectin/neuroprotectin and fatty acids in the n3 and n6 pathways will be measured. | Baseline to 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in infant weigh | Recorded in grams (ounces) | Baseline to 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchopulmonary dysplasia (BDP) | Percentage of participants with BDP | Baseline to 36 weeks |
| Late-onset sepsis (LOS) | Percentage of participants with LOS |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Blanco, MD, MSCI-TS | Contact | 210-567-5225 | blanco@uthscsa.edu | |
| Diana Anzueto Guerra | Contact | 210-567-5254 | anzuetod@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Cynthia Blanco, MD, MSCI-TS | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles (UCLA) | Recruiting | Los Angeles | California | 90404 | United States |
Deidentified data will be shared with the funding body, NIH, summary results will be shared in ClinicalTrials.gov
Data will be shared at completion of the study when data analysis has occure.
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There will be four arms of the trial encompassing the period from enrollment to 36 weeks' postmenstrual age: (a) DHA/ARA supplement throughout the duration of the protocol, "d-on"; (b) no DHA/ARA supplement throughout the duration of the protocol, "d-off"; (c) a cross-over arm of DHA/ARA supplement from enrollment to 31 6/7 weeks post-menstrual age (PMA) then no supplement from 32 to 36 weeks' PMA, "x- on/off"; and (d) a cross-over arm of no DHA/ARA supplement till 31 6/7 weeks' then long-chain polyunsaturated fatty acids (LCPUFA) supplement from 32 to 36 weeks PMA, "x-off/on".
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| Baseline to 36 weeks |
| Retinopathy of prematurity (ROP) | Percentage of participants with ROP | Baseline to 36 weeks |
| Necrotizing enterocolitis (NEC) | Percentage of participants with NEC | Baseline to 36 weeks |
| Yale New Haven Hospital | Recruiting | New Haven | Connecticut | 06511 | United States |
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| Ann & Robert H. Lurie Children's Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
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| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
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| Weill Cornell Medicine | Recruiting | New York | New York | 10021 | United States |
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| University Health System | Recruiting | San Antonio | Texas | 78229 | United States |
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| University of Texas Health Science Center at San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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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 |
| D000091642 | Urogenital Diseases |
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