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Dietary Supplement

DHA & ARA Supplementation for Prematurity

N/A
Recruiting
Led By Cynthia Blanco, MD, MSCI-TS
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Born between 25 0/7 and 29 6/7 weeks of gestation
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 36 weeks
Awards & highlights

Study Summary

This trial looks at the effects of DHA and ARA supplementation on lipid metabolism and how it impacts important biological pathways.

Who is the study for?
This trial is for preterm infants born between 25 and just under 30 weeks of gestation, who are less than 48 hours old when they receive their first lipid dose. Infants needing surgery before discharge or anticipated to require withdrawal from intensive care within the first 72 hours, as well as those with serious congenital anomalies, cannot participate.Check my eligibility
What is being tested?
The study is examining how a special dietary supplement called Enfamil® DHA & ARA affects fat metabolism in premature babies. It looks at whether these supplements influence biological processes like metabolism, inflammation response, and development of organs.See study design
What are the potential side effects?
As this trial involves nutritional supplementation in vulnerable preterm infants, potential side effects may include digestive disturbances or alterations in growth patterns; however specific side effects will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was born between 25 and 29 weeks of pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Protectin/Neuroprotectin
Change in biomarker Resolvin D1
Change in biomarker Resolvin E1
+3 more
Secondary outcome measures
Change in infant weigh
Other outcome measures
Bronchopulmonary dysplasia (BDP)
Late-onset sepsis (LOS)
Necrotizing enterocolitis (NEC)
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: No supplement initially then DHA/ARA supplementExperimental Treatment1 Intervention
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"
Group II: DHA/ARA supplementExperimental Treatment1 Intervention
DHA/ARA supplement throughout the duration of the protocol, "d-on"
Group III: DHA/ARA initially then no supplementExperimental Treatment1 Intervention
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"
Group IV: No DHA/ARA supplementActive Control1 Intervention
no DHA/ARA supplement throughout the duration of the protocol, "d-off"

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,082 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,672,254 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,700 Previous Clinical Trials
7,506,548 Total Patients Enrolled

Media Library

Enfamil® DHA & ARA Supplement for Special Dietary Use (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05380401 — N/A
Premature Research Study Groups: DHA/ARA supplement, No DHA/ARA supplement, DHA/ARA initially then no supplement, No supplement initially then DHA/ARA supplement
Premature Clinical Trial 2023: Enfamil® DHA & ARA Supplement for Special Dietary Use Highlights & Side Effects. Trial Name: NCT05380401 — N/A
Enfamil® DHA & ARA Supplement for Special Dietary Use (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05380401 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still accepting participants for this experiment?

"The clinical trial, which was initially launched on October 1st 2022 and last updated on September 8th 2022, is not presently looking for participants. However, there are still 267 other trials that require volunteer patients at this juncture in time."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants
2023. "Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05380401.
~219 spots leftby Apr 2027
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