Investigations on Improving Docosahexaenoic and Arachidonic Acid Content in Preterm Infant Formula
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 66
- Locations
- 5
- Primary Endpoint
- plasma phospholipid fatty acid composition
Study Overview
Brief Summary
The investigators examined the effect of different levels of docosahexaenoic aicd (a long chain polyunsaturated fatty acid) intake on the fatty acid composition of plasma and erythrocyte phospholipids and on the maturity of visually evoked potentials in preterm infants. As a secondary outcome the conversion of linoleic acid and alpha linolenic acid into their corresponding long chain polyunsaturated fatty acids was studied.
Preterm infants were randomized in a double-blind fashion to one of three formulas containing different amounts of docosahexaenoic acid during the first two weeks of postnatal life. A control group received human milk. Blood samples were collected at study entry and 14 and 28 days thereafter. Uniformly 13C-labeled linoleic acid and alpha linolenic acid were applied orally before blood sampling at day 28. At postconceptional ages 48 weeks and 56 weeks visually evoked potentials were recorded.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 14 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •preterm birth
- •birth weight between 1000 and 2200 g
- •more than 80 % of energy intake from infant formula or human milk at enrollment
Exclusion Criteria
- •apparent genetic, gastrointestinal or metabolic disorders
- •artificial ventilation or oxygen supply > 30% at the time of enrollment
- •administration of parenteral fat emulsion (> 1 g/kg/day for more than seven days) before or after study entry
Arms & Interventions
medium docosahexaenoic acid formula
Intervention: medium docosahexaenoic acid formula (Dietary Supplement)
high docosahexaenoic acid formula
Intervention: high docosahexaenoic acid formula (Dietary Supplement)
human milk
Intervention: breast milk (Dietary Supplement)
low docosahexaenoic acid formula
Intervention: low docosahexaenoic acid formula (Dietary Supplement)
Outcomes
Primary Outcomes
plasma phospholipid fatty acid composition
Time Frame: 28 days after intervention start
visually evoked potentials
Time Frame: 48 weeks and 56 weeks postconceptional age
Secondary Outcomes
- intensity of endogenous conversion of essential fatty acids into long chain polyunsaturated fatty acids(28 days after study start)