Summary

Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

Official Title

Metabolic Mechanisms Induced by Enteral Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA) Supplementation in Preterm Infants

Details

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.

Keywords

Premature, infant, premature, fatty acids, nutrition, Premature Birth, Enfamil® DHA & ARA Supplement for Special Dietary Use, DHA/ARA supplement

Eligibility

You can join if…

  • 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.)

You CAN'T join if...

  • 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

Locations

  • University of California, Los Angeles (UCLA) accepting new patients
    Los Angeles California 90404 United States
  • University Health System accepting new patients
    San Antonio Texas 78229 United States
  • University of Texas Health Science Center at San Antonio accepting new patients
    San Antonio Texas 78229 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
The University of Texas Health Science Center at San Antonio
ID
NCT05380401
Study Type
Interventional
Participants
Expecting 328 study participants
Last Updated