Clinical trial NCT05380401: Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants
Official title: Metabolic Mechanisms Induced by Enteral Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA) Supplementation in Preterm Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature
Keywords: infant, premature
fatty acids
nutrition
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-05-18
Enrollment: 328
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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".
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fatty acid levels in plasma
timeFrame: Baseline to 36 weeks
measure: Fatty acid levels in red blood cell (RBC) membranes
timeFrame: Baseline to 36 weeks
measure: Change in circulating biomarker Lipoxin A4
timeFrame: Baseline to 36 weeks
measure: Change in biomarker Resolvin D1
timeFrame: Baseline to 36 weeks
measure: Change in biomarker Resolvin E1
timeFrame: Baseline to 36 weeks
measure: Change in Protectin/Neuroprotectin
timeFrame: Baseline to 36 weeks
Secondary outcomes:
measure: Change in infant weigh
timeFrame: Baseline to 36 weeks
Other outcomes:
measure: Bronchopulmonary dysplasia (BDP)
timeFrame: Baseline to 36 weeks
measure: Late-onset sepsis (LOS)
timeFrame: Baseline to 36 weeks
measure: Retinopathy of prematurity (ROP)
timeFrame: Baseline to 36 weeks
measure: Necrotizing enterocolitis (NEC)
timeFrame: Baseline to 36 weeks
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles (UCLA)
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: San Antonio
country: United States
facility: University Health System
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Cynthia Blanco, MD, MSCI-TS
role: PRINCIPAL_INVESTIGATOR
References: