N/A
N=60
Bridging the Docosahexaenoic Acid (DHA) Gap: The Effects of Omega-3 Fatty Acid Supplementation in Premature Infants
Prematurity
Bottom Line
View on ClinicalTrials.gov: NCT01908907 ↗Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Apr 2018
Primary outcome: Primary: Days to Reach Full Enteral Feedings and Days on Study Oil. — 20.00; 16.21; 34.00; 33.71 days — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DHA oil (Dietary_supplement); (MCT) Control oil (Dietary_supplement)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sanford Health
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days to Reach Full Enteral Feedings and Days on Study Oil. |
20.00; 16.21; 34.00; 33.71 | 0.07 |
| PRIMARY Feasibility and Tolerability of Daily Enteral DHA Oil - Weight Change |
18.4; 18.4 | 0.048 sig |
| PRIMARY Long Chain Polyunsaturated Fatty Acid (LCPUFA) Levels - Docosahexaenoic Acid (DHA) Levels in Whole Blood |
2.91; 2.88; 2.83; 3.03; 2.87; 3.55 | — |
| PRIMARY Feasibility and Tolerability of Daily Enteral DHA Oil - Length Change |
0.13; 0.12 | — |
| PRIMARY Feasibility and Tolerability of Daily Enteral DHA Oil - Head Circumference |
0.10; 0.10 | — |
| SECONDARY LCPUFA Levels - Arachidonic Acid (ARA) in Whole Blood |
13.21; 14.89; 14.35; 14.87; 14.31; 13.94 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01908907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.