Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants
- Conditions
- Premature
- Interventions
- Dietary Supplement: Enfamil® DHA & ARA Supplement for Special Dietary Use
- Registration Number
- NCT05380401
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 328
- 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.)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DHA/ARA supplement Enfamil® DHA & ARA Supplement for Special Dietary Use DHA/ARA supplement throughout the duration of the protocol, "d-on" DHA/ARA initially then no supplement Enfamil® DHA & ARA Supplement for Special Dietary Use 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 Enfamil® DHA & ARA Supplement for Special Dietary Use 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"
- Primary Outcome Measures
Name Time Method Fatty acid levels in red blood cell (RBC) membranes Baseline to 36 weeks Change in fatty acid levels in RBC membranes
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.
Change in Protectin/Neuroprotectin Baseline to 36 weeks Levels of protectin/neuroprotectin and fatty acids in the n3 and n6 pathways will be measured.
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.
Fatty acid levels in plasma Baseline to 36 weeks Change in lipid metabolites reflected by levels in plasma
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.
- Secondary Outcome Measures
Name Time Method Change in infant weigh Baseline to 36 weeks Recorded in grams (ounces)
Trial Locations
- Locations (7)
Northwestern University
🇺🇸Chicago, Illinois, United States
University of California, Los Angeles (UCLA)
🇺🇸Los Angeles, California, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
University Health System
🇺🇸San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States