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
|Condition or disease||Intervention/treatment||Phase|
|Retinopathy of Prematurity||Drug: Omegaven||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
Other Name: Omega-3
- 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.
- 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
- 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.
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
|Contact: Sarah Lazar, MPHfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Shira L. Robbins, M.D.||University of California, San Diego|