Skip to main content
Clinical Trials/NCT05380401
NCT05380401RecruitingNot Applicable

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

The University of Texas Health Science Center at San Antonio13 sites in 1 country328 target enrollmentStarted: March 9, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
328
Locations
13
Primary Endpoint
Fatty acid levels in red blood cell (RBC) membranes

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
— to 36 Weeks (Child)
Sex
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

Arms & Interventions

DHA/ARA initially then no supplement

Other

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"

Intervention: Enfamil® DHA & ARA Supplement for Special Dietary Use (Dietary Supplement)

DHA/ARA supplement

Other

DHA/ARA supplement throughout the duration of the protocol, "d-on"

Intervention: Enfamil® DHA & ARA Supplement for Special Dietary Use (Dietary Supplement)

No DHA/ARA supplement

No Intervention

no DHA/ARA supplement throughout the duration of the protocol, "d-off"

No supplement initially then DHA/ARA supplement

Other

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"

Intervention: Enfamil® DHA & ARA Supplement for Special Dietary Use (Dietary Supplement)

Outcomes

Primary Outcomes

Fatty acid levels in red blood cell (RBC) membranes

Time Frame: Baseline to 36 weeks

Change in fatty acid levels in RBC membranes

Change in biomarker Resolvin E1

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: Baseline to 36 weeks

Change in lipid metabolites reflected by levels in plasma

Change in biomarker Resolvin D1

Time Frame: 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 Outcomes

  • Change in infant weigh(Baseline to 36 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (13)

Loading locations...

Similar Trials