Omega-3 LCPUFA Supplementation in Very Low Birth Weight Infants for The Prevention Retinopathy of Prematurity
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular, Ocular, Women's Studies |
| Therapuetic Areas: | Ophthalmology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/17/2018 |
| Start Date: | March 2014 |
| End Date: | January 2019 |
| Contact: | Bridge Renee, RN |
| Email: | rbridge@ucsd.edu |
| Phone: | 619-665-5632 |
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
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.
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.
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.
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.
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
We found this trial at
1
site
San Diego, California 92121
Phone: 619-665-5632
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