Bridging the Docosahexaenoic Acid (DHA) Gap: The Effects of Omega-3 Fatty Acid Supplementation in Premature Infants
Condition: Prematurity
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): DHA oil; (MCT) Control oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Therapy Group:DHA oil administered at 50 mg/d (0.18ml) as an oil emulsion enterally with feedings or by gavage tube if the infant has one.; Placebo Group:MCT oil administered at 0.18 ml as an oil emulsion enterally with feedings or by gavage tube if the infant has one.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Premature Infants; DHA(docosahexaenoic acid); DHA deficit