Bridging the Docosahexaenoic Acid (DHA) Gap: The Effects of Omega-3 Fatty Acid Supplementation in Premature Infants
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/23/2019 |
| Start Date: | October 2012 |
| End Date: | February 2014 |
The purpose of this study is to understand if the "DHA gap" can be corrected by giving a
daily dose of DHA oil to preterm babies.
DHA is an essential omega-3 fatty acid, which means our body cannot make DHA. We have to take
it in through our diet. DHA is important for normal brain and eye health and it may also
decrease inflammation. This is important for premature babies because they are at a greater
risk for getting diseases related to inflammation, especially in their lungs, eyes and
intestines. Since DHA is so important for normal growth, you will find DHA naturally in
breast milk and it is now added to infant formula. But the amount in breast milk and infant
formula is about half of what your infant should expect to get in the womb (about 13-29mg per
day in breast milk vs. 50-75mg per day in the womb). Very premature babies are at an even
greater disadvantage because they cannot always eat very much right away and that is the only
way they can get essential fatty acids in their body. This means premature babies are getting
less DHA than they would in the womb and then the "DHA gap" continues for a longer period of
time. This gap also comes at a time when their brain is growing most rapidly and their bodies
need it the most. This trial is designed to see if giving DHA, even before the baby can take
food orally, will raise his/her DHA blood levels to those of normal term babies.
daily dose of DHA oil to preterm babies.
DHA is an essential omega-3 fatty acid, which means our body cannot make DHA. We have to take
it in through our diet. DHA is important for normal brain and eye health and it may also
decrease inflammation. This is important for premature babies because they are at a greater
risk for getting diseases related to inflammation, especially in their lungs, eyes and
intestines. Since DHA is so important for normal growth, you will find DHA naturally in
breast milk and it is now added to infant formula. But the amount in breast milk and infant
formula is about half of what your infant should expect to get in the womb (about 13-29mg per
day in breast milk vs. 50-75mg per day in the womb). Very premature babies are at an even
greater disadvantage because they cannot always eat very much right away and that is the only
way they can get essential fatty acids in their body. This means premature babies are getting
less DHA than they would in the womb and then the "DHA gap" continues for a longer period of
time. This gap also comes at a time when their brain is growing most rapidly and their bodies
need it the most. This trial is designed to see if giving DHA, even before the baby can take
food orally, will raise his/her DHA blood levels to those of normal term babies.
Docosahexaenoic acid (DHA) is an essential fatty acid (FA) important for health and
neurodevelopment. Premature infants are at risk of DHA deficiency and circulating levels
directly correlate with health outcomes. Most supplementation strategies have focused on
increasing DHA content in mother's milk or infant formula. However, extremely premature
infants may not reach full feedings for weeks and commercially available parenteral lipid
emulsions do not contain preformed DHA, so blood levels decline rapidly after birth. Our
objective is to develop a DHA supplementation strategy to overcome these barriers. This
single-center, double-blind, randomized, controlled trial determined feasibility,
tolerability and efficacy of daily enteral DHA supplementation (50 mg/day) in addition to
standard nutrition for preterm infants (24-34 weeks gestational age) beginning in the first
week of life. Blood FA levels will be analyzed at baseline, full feedings and near discharge
in DHA or placebo supplemented preterm infants. Term peers will also have blood FA levels
analyzed for comparison. Growth, feeding tolerance and adverse outcomes (NEC,
intraventricular hemorrhage (IVH), thrombocytopenia, sepsis) will be evaluated. Study
progress and safety will be monitored by an external Data Safety Monitoring Board (DSMB).
Overall, the study aims to determine if daily enteral DHA supplementation is feasible and
alleviates deficiency in premature infants.
neurodevelopment. Premature infants are at risk of DHA deficiency and circulating levels
directly correlate with health outcomes. Most supplementation strategies have focused on
increasing DHA content in mother's milk or infant formula. However, extremely premature
infants may not reach full feedings for weeks and commercially available parenteral lipid
emulsions do not contain preformed DHA, so blood levels decline rapidly after birth. Our
objective is to develop a DHA supplementation strategy to overcome these barriers. This
single-center, double-blind, randomized, controlled trial determined feasibility,
tolerability and efficacy of daily enteral DHA supplementation (50 mg/day) in addition to
standard nutrition for preterm infants (24-34 weeks gestational age) beginning in the first
week of life. Blood FA levels will be analyzed at baseline, full feedings and near discharge
in DHA or placebo supplemented preterm infants. Term peers will also have blood FA levels
analyzed for comparison. Growth, feeding tolerance and adverse outcomes (NEC,
intraventricular hemorrhage (IVH), thrombocytopenia, sepsis) will be evaluated. Study
progress and safety will be monitored by an external Data Safety Monitoring Board (DSMB).
Overall, the study aims to determine if daily enteral DHA supplementation is feasible and
alleviates deficiency in premature infants.
Inclusion Criteria:
- Preterm infants between 24 and 33 6/7 weeks gestation
- must be less than or equal to 1 week of age
Exclusion Criteria:
- infants who are considered by the medical team to be non-viable
- infants with multiple or severe congenital anomalies such as gastroschisis, congenital
chylothorax or other illnesses that do not allow a feeding tube to be placed or
utilized at 7 days of age.
- term infants: who are born to mothers with diabetes or are small for gestational age
(SGA-less than the 10th% for adjusted gestational age
- All families consented for this study will need to be able to read and write English
- Mother must be 18 years of age or older
- Taking Omegaven
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