Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants

ConditionPremature

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeUp to 36

SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Enfamil® DHA & ARA Supplement for Special Dietary Use
Dietary supplement
Dosage: 60 mg/kg/day of DHA and 120 mg/kg/day of ARA. Route of administration: enteral tube or by oral syringe

Treatment groups

328 Participants

are divided into 4 treatment groups

Group A: DHA/ARA supplementOther 1 intervention

Group B: No DHA/ARA supplementNo intervention 0 interventions

Group C: DHA/ARA initially then no supplementOther 1 intervention

Group D: No supplement initially then DHA/ARA supplementOther 1 intervention

Trial outcomes

Primary outcomes

Fatty acid levels in plasma

Change in lipid metabolites reflected by levels in plasma

Time frame

Baseline to 36 weeks

Fatty acid levels in red blood cell (RBC) membranes

Change in fatty acid levels in RBC membranes

Time frame

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.

Time frame

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.

Time frame

Baseline to 36 weeks

Secondary outcomes

Change in infant weigh

Recorded in grams (ounces)

Time frame

Baseline to 36 weeks

Other outcomes

Bronchopulmonary dysplasia (BDP)

Percentage of participants with BDP

Time frame

Baseline to 36 weeks

Late-onset sepsis (LOS)

Percentage of participants with LOS

Time frame

Baseline to 36 weeks

Retinopathy of prematurity (ROP)

Percentage of participants with ROP

Time frame

Baseline to 36 weeks

Necrotizing enterocolitis (NEC)

Percentage of participants with NEC

Time frame

Baseline to 36 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center at San Antonio

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov

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