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Omega-3 Long Chain Polyunsaturated Fatty Acid (LCPUFA) Supplementation in Very Low Birth Weight Infants for The Prevention Retinopathy of Prematurity

Sponsor
University of California, San Diego (Other)
Overall Status
Completed
CT.gov ID
NCT02486042
Collaborator
The Hartwell Foundation (Other)
47
Enrollment
1
Location
2
Arms
69
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Omegaven
  • Dietary Supplement: Standard lipids (primarily omega-6 fatty acids)
 Phase 2

Detailed Description

Approximately 517,000 infants are born prematurely every year. As low birth weight and premature infants are surviving longer, they are at risk of developing severe retinopathy of prematurity (ROP).

ROP is a disease of the eye affecting prematurely-born babies. It is thought to be caused by disorganized growth of retinal blood vessels which may result in scarring and retinal detachment. ROP can be mild and may resolve spontaneously, but it may lead to blindness in serious cases. ROP is the leading cause of irreversible childhood blindness in the United States. As such, all preterm babies are at risk for ROP, and very low birth weight is an important risk factor.

Researchers have found that increasing omega-3 fatty acids and decreasing omega-6 fatty acids in the diet of mice with eye disease similar to ROP had reduced areas of blood vessel loss and abnormal blood vessel growth. These findings represent new evidence suggesting the possibility that omega-3 fatty acids act as protective factors in diseases that affect retinal blood vessels.

Omega-3 fatty acids make compounds that protect against the growth of abnormal blood vessels by preventing inflammation.

In two European studies, this treatment decreased the risk of needing laser treatment in the eye for ROP. This study has not yet been repeated in the United States. The purpose of this study is to learn how omega-3 fatty acid supplementation in low birth weight infants changes the blood profile of infants receiving this nutritional treatment.

Infants are enrolled in this study shortly after birth and receive IV and/or oral supplementation until they are full term or the retinal blood vessels have completely developed, shortly after term. Once the treatment is over, these infants will continue to be followed for growth and development of their eyes.

Study Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
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
Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard of Care (Standard Nutrition)

Infants in this group will receive standard lipids (predominantly Omega-6 fatty acids).

Dietary Supplement: Standard lipids (primarily omega-6 fatty acids)
Infants will receive nutritional supplementation with standard intralipid, composed primarily of omega-6 fatty acids.
Other Names:
  • Intralipid

    		•
    Experimental: Omegaven

    Infants in this group will receive lipid supplementation with omega-3 fatty acids.

    Drug: Omegaven
    Infants will receive nutritional supplementation with omega-3 fatty acids (omegaven).
    Other Names:
  • Omega-3

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Basic Fatty Acid Concentrations [Prior to parenteral nutrition; 5 days after parenteral nutrition is started;5 days after enteral nutrition full feeds have arrived; Prior to discharge from hospital coinciding with time that ROP may be present, ≥35 weeks adjusted age]

      Change in concentrations of basic fatty acids (EPA, DHA, and AA) and their bio-active metabolites (resolvins and neuroprotectins) will be assessed at time points: T0, T2 and T3.

    Secondary Outcome Measures

    1. Change in mRNA Expression [Prior to parenteral nutrition; 5 days after parenteral nutrition is started;5 days after enteral nutrition full feeds have arrived; Prior to discharge from hospital coinciding with time that ROP may be present, ≥35 weeks adjusted age]

      Change in mRNA expression of TNF-α, PPAR-ɣ, and VEGF

    2. Severity of ROP in Arm 1 vs. Arm 2 [40 weeks (adjusted age = gestation + post-natal age)]

      Severity stage of ROP in Arm 1 compared to Arm 2. This will be assessed at the time of ROP screening (approximately 31 weeks), and the outcome will be measured at 40 weeks adjusted age. The stage of ROP at 40 weeks adjusted will be used for statistical analyses.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 7 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 LFTs.

    • ≤ 500 grams birthweight

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, San Diego Jacobs Medical Center La Jolla California United States 92037

    Sponsors and Collaborators

    • University of California, San Diego
    • The Hartwell Foundation

    Investigators

    • Principal Investigator: Shira L. Robbins, M.D., University of California, San Diego

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Shira Robbins, Clinical Professor, University of California, San Diego
    ClinicalTrials.gov Identifier:
    NCT02486042
    Other Study ID Numbers:
    • 140253
    First Posted:
    Jun 30, 2015
    Last Update Posted:
    Dec 17, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Shira Robbins, Clinical Professor, University of California, San Diego
    ROP
    Premature infant
    Additional relevant MeSH terms:
    Retinal Diseases
    Retinopathy of Prematurity
    Premature Birth
    Birth Weight
    Soybean oil, phospholipid emulsion

    Study Results

    No Results Posted as of Dec 17, 2021