CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Omegaven +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02486042
NCT02486042Phase 2Completed

Omega-3 Long Chain Polyunsaturated Fatty Acid (LCPUFA) Supplementation in Very Low Birth Weight Infants for The Prevention Retinopathy of Prematurity: Proposal for a Prospective Randomized Controlled Masked Clinical Trial With Lipidomic and Transcriptomic Analyses

University of California, San Diego·interventional·Posted Jun 30, 2015·Updated Dec 29, 2022

In Brief

A Phase 2 clinical trial evaluating Omegaven and Standard lipids (primarily omega-6 fatty acids) for Retinopathy of Prematurity. Completed, enrolled 48 participants across 1 site.

Detailed Summary

Retinopathy of prematurity (ROP) is a blinding disease affecting infants born prematurely. These infants do not have enough essential fatty acids to structurally support the retina, the nerve tissue in the eye which allows us to see. A recent study showed that giving omega-3 (n-3) fatty acids to these infants soon after birth made them less likely to need invasive treatments for eye disease. This research trial will give young infants born prematurely n-3 fish oil treatment and look at how this changes factors in the blood that promote disease. Detailed blood studies comparing infants with and without ROP will be performed and the infants will be followed over time to assess their eye development.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 30, 2015
Enrollment StartMar 1, 2014
Primary CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 11.0 years ago

Interventions

Omegavendrug

Infants will receive nutritional supplementation with omega-3 fatty acids (omegaven).

Standard lipids (primarily omega-6 fatty acids)dietary

Infants will receive nutritional supplementation with standard intralipid, composed primarily of omega-6 fatty acids.