Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants
2 other identifiers
interventional
328
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2022
CompletedFirst Posted
Study publicly available on registry
May 18, 2022
CompletedStudy Start
First participant enrolled
March 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
September 24, 2025
September 1, 2025
4.1 years
April 22, 2022
September 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Fatty acid levels in plasma
Change in lipid metabolites reflected by levels in plasma
Baseline to 36 weeks
Fatty acid levels in red blood cell (RBC) membranes
Change in fatty acid levels in RBC membranes
Baseline to 36 weeks
Change in circulating biomarker Lipoxin A4
Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.
Baseline to 36 weeks
Change in biomarker Resolvin D1
Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.
Baseline to 36 weeks
Change in biomarker Resolvin E1
Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.
Baseline to 36 weeks
Change in Protectin/Neuroprotectin
Levels of protectin/neuroprotectin and fatty acids in the n3 and n6 pathways will be measured.
Baseline to 36 weeks
Secondary Outcomes (1)
Change in infant weigh
Baseline to 36 weeks
Other Outcomes (4)
Bronchopulmonary dysplasia (BDP)
Baseline to 36 weeks
Late-onset sepsis (LOS)
Baseline to 36 weeks
Retinopathy of prematurity (ROP)
Baseline to 36 weeks
- +1 more other outcomes
Study Arms (4)
DHA/ARA supplement
OTHERDHA/ARA supplement throughout the duration of the protocol, "d-on"
No DHA/ARA supplement
NO INTERVENTIONno DHA/ARA supplement throughout the duration of the protocol, "d-off"
DHA/ARA initially then no supplement
OTHERDHA/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
OTHERNo 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"
Interventions
Dosage: 60 mg/kg/day of DHA and 120 mg/kg/day of ARA. Route of administration: enteral tube or by oral syringe
Eligibility Criteria
You may qualify 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 may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of California, Los Angeles (UCLA)
Los Angeles, California, 90404, United States
Yale New Haven Hospital
New Haven, Connecticut, 06511, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Northwestern University
Chicago, Illinois, 60611, United States
Weill Cornell Medicine
New York, New York, 10021, United States
University Health System
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cynthia Blanco, MD, MSCI-TS
University of Texas Health Science Center San Antonio
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2022
First Posted
May 18, 2022
Study Start
March 9, 2023
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
September 24, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be shared at completion of the study when data analysis has occure.
Deidentified data will be shared with the funding body, NIH, summary results will be shared in ClinicalTrials.gov