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Purpose

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.

Condition

Eligibility

Eligible Ages
Under 36 Weeks
Eligible Genders
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
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
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
DHA/ARA supplement 		DHA/ARA supplement throughout the duration of the protocol, "d-on"
  • Dietary Supplement: Enfamil® 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
    Other names:
    • DHA/ARA Supplement
No Intervention
No DHA/ARA supplement 		no DHA/ARA supplement throughout the duration of the protocol, "d-off"
Other
DHA/ARA initially then no supplement 		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"
  • Dietary Supplement: Enfamil® 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
    Other names:
    • DHA/ARA Supplement
Other
No supplement initially then DHA/ARA supplement 		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"
  • Dietary Supplement: Enfamil® 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
    Other names:
    • DHA/ARA Supplement

Recruiting Locations

University Health System
San Antonio, Texas 78229
Contact:
Diana Anzueto Guerra, MS
210-567-5254
anzuetod@uthscsa.edu

University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
Cynthia Blanco, MD
blanco@uthscsa.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Cynthia Blanco, MD, MSCI-TS
210-567-5225
blanco@uthscsa.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.