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Omega-3 LCPUFA Supplementation in Very Low Birth Weight Infants for The Prevention Retinopathy of Prematurity

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ClinicalTrials.gov Identifier: NCT02486042
Recruitment Status : Recruiting
First Posted : June 30, 2015
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
The Hartwell Foundation
Information provided by (Responsible Party):
Shira Robbins, University of California, San Diego

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
Retinopathy of Prematurity Drug: Omegaven 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Omega-3 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 : March 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
No Intervention: Standard Nutrition
Infants in this group will receive the standard intravenous nutrition with predominantly Omega-6 fatty acids.
Experimental: Omega-3 Group/Added Nutrition
Infants in this group will receive the experimental intravenous nutrition with Omega-3 fatty acids known as Omegaven in addition to standard nutrition.
Drug: Omegaven
Other Name: Omega-3




Primary Outcome Measures :
  1. Basic Fatty Acid Concentrations [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 LFTs.
  • ≤ 500 grams birthweight

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02486042


Contacts
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Contact: Sarah Lazar, MPH 858-249-1711 slazar@ucsd.edu

Locations
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United States, California
University of California, San Diego Jacobs Medical Center Recruiting
La Jolla, California, United States, 92037
Contact: Sarah Lazar, MPH    858-249-1711    slazar@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
The Hartwell Foundation
Investigators
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Principal Investigator: Shira L. Robbins, M.D. University of California, San Diego

Publications:
Born Too Soon | March of Dimes. March Dimes Found. Partnersh. Matern. Newborn Child Heal. Save Child. World Heal. Organ. 2012. Available at: http://www.marchofdimes.com/mission/global-preterm.aspx.

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Responsible Party: Shira Robbins, Clinical Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02486042     History of Changes
Other Study ID Numbers: 140253
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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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, University of California, San Diego:
ROP
Premature infant
Additional relevant MeSH terms:
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Retinal Diseases
Retinopathy of Prematurity
Premature Birth
Birth Weight
Eye Diseases
Body Weight
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases