Premature
Conditions
Keywords
infant, premature, fatty acids, nutrition
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTEnfamil® DHA & ARA Supplement for Special Dietary Use
Dosage: 60 mg/kg/day of DHA and 120 mg/kg/day of ARA. Route of administration: enteral tube or by oral syringe
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 36 Weeks
Healthy volunteers
No
Inclusion criteria
* born between 25 0/7 and 29 6/7 weeks of gestation * less than 48 hours of age at first lipid dose (The cohort is defined by gestational age rather than birth weight to avoid an over-represented sample of growth-restricted infants in birth weight defined cohorts.)
Exclusion criteria
* serious congenital anomalies * conditions at birth that will require surgery prior to discharge * imminent death such that withdrawal of intensive care support is anticipated within the first 72 hours after birth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Protectin/Neuroprotectin | Baseline to 36 weeks | Levels of protectin/neuroprotectin and fatty acids in the n3 and n6 pathways will be measured. |
| Fatty acid levels in plasma | Baseline to 36 weeks | Change in lipid metabolites reflected by levels in plasma |
| Fatty acid levels in red blood cell (RBC) membranes | Baseline to 36 weeks | Change in fatty acid levels in RBC membranes |
| Change in circulating biomarker Lipoxin A4 | Baseline to 36 weeks | Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates. |
| Change in biomarker Resolvin D1 | Baseline to 36 weeks | Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates. |
| Change in biomarker Resolvin E1 | Baseline to 36 weeks | Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in infant weigh | Baseline to 36 weeks | Recorded in grams (ounces) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Late-onset sepsis (LOS) | Baseline to 36 weeks | Percentage of participants with LOS |
| Retinopathy of prematurity (ROP) | Baseline to 36 weeks | Percentage of participants with ROP |
| Necrotizing enterocolitis (NEC) | Baseline to 36 weeks | Percentage of participants with NEC |
| Bronchopulmonary dysplasia (BDP) | Baseline to 36 weeks | Percentage of participants with BDP |
Countries
United States
Contacts
Primary ContactCynthia Blanco, MD, MSCI-TS
Backup ContactDiana Anzueto Guerra
Outcome results
None listed