Phase 2
N=41
Omega-3 Long Chain Polyunsaturated Fatty Acid (LCPUFA) Supplementation in Very Low Birth Weight Infants for The Prevention Retinopathy of Prematurity
Retinopathy of Prematurity
Bottom Line
View on ClinicalTrials.gov: NCT02486042 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Changes in mRNA Expression in Blood of STAT3, PPAR-ɣ, and STC-1 at T0 — 4.19; 7.58; 6.43; 11.32 delta Ct (amplification cycles) — p=0.22
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Omegaven (Drug); Standard lipids (primarily omega-6 fatty acids) (Dietary_supplement)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in mRNA Expression in Blood of STAT3, PPAR-ɣ, and STC-1 at T0 |
4.19; 7.58; 6.43; 11.32; 22.21; 21.03 | 0.22 |
| PRIMARY Changes in mRNA Expression in Blood of STAT3, PPAR-ɣ, and STC-1 at T1 |
5.28; 6.98; 8.60; 10.51; 20.73; 23.09 | 0.43 |
| PRIMARY Changes in mRNA Expression in Blood of STAT3, PPAR-gamma, and STC-1 at T2 |
11.12; 4.66; 18.67; 7.31; 28.42; 18.66 | 0.001 sig |
| PRIMARY Changes in mRNA Expression in Blood of STAT3 and PPAR-ɣ at T3 |
3.90; 9.94; 9.15; 16.11 | — |
| SECONDARY Pilot Assay of Basic Fatty Acid Concentrations in Blood at Time T2 |
6826; 132669; 61541; 229583; 334721; 345122 | — |
| SECONDARY Percentage of Eyes at the Furthest Stage of ROP Achieved |
76.3; 42.1; 5.3; 7.9; 18.4; 26.3 | — |
| SECONDARY Number of Patients Requiring Laser Treatment in Arm 1 Versus Arm 2 |
0; 5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Infants born less than or equal to 30 weeks gestation or less than 1500 g at birth
Exclusion Criteria
- Patients with liver disease as tested by liver function tests (LFTs)
- ≤ 500 grams birthweight
Data sourced from ClinicalTrials.gov (NCT02486042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.