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NCT02486042 · ClinicalTrials.gov registry record · Phase 2
Omega-3 Long Chain Polyunsaturated Fatty Acid (LCPUFA) Supplementation in Very Low Birth Weight Infants for The Prevention Retinopathy of Prematurity
A Phase 2 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT02486042: Completed Phase 2 study, sponsored by University of California, San Diego.
NCT02486042 is a Phase 2 study that has completed, run by University of California, San Diego. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02486042, a Phase 2 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study 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.
Primary Outcome
Calculated using RNA extraction from blood, then quantitative polymerase chain reaction (qPCR) analysis. Biomarker significance: STAT3: role in hypoxia pathway leading to ROP (retinopathy of prematurity). Higher STAT3=greater ROP risk PPAR-ɣ: protective anti-angiogenic factor. Higher PPAR-ɣ=lower ROP risk STC-1: stress response protein. Higher STC-1=lower ROP risk Delta Ct meaning: qPCR gene expression analysis outputs Ct values for each genetic sample tested. A Ct value is the number of q
Interventions
- DRUG Omegaven
- DIETARY_SUPPLEMENT Standard lipids (primarily omega-6 fatty acids)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2014-03 |
| Est. Completion | 2019-12 |
| Phase | Phase 2 |
What the finished NCT02486042 record still lists
NCT02486042 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Omegaven is the first listed.
NCT02486042 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02486042 about?
NCT02486042 is a clinical study titled "Omega-3 Long Chain Polyunsaturated Fatty Acid (LCPUFA) Supplementation in Very Low Birth Weight Infants for The Prevention Retinopathy of Prematurity". 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 the...
What is the current status of trial NCT02486042?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2014-03. Estimated completion is 2019-12.
What interventions are being tested in trial NCT02486042?
The interventions under investigation include: Omegaven (DRUG), Standard lipids (primarily omega-6 fatty acids) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02486042?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02486042's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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