Prematurity of Fetus
Conditions
Keywords
neurological development, preterm infants, fatty acid status
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.
Interventions
DIETARY_SUPPLEMENTlow docosahexaenoic acid formula
DIETARY_SUPPLEMENTmedium docosahexaenoic acid formula
DIETARY_SUPPLEMENThigh docosahexaenoic acid formula
DIETARY_SUPPLEMENTbreast milk
a non randomized group of breast milk fed infants was included
Sponsors
Société des Produits Nestlé (SPN)
German Federal Ministry of Education and Research
German Research Foundation
Ludwig-Maximilians - University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Days
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma phospholipid fatty acid composition | 28 days after intervention start |
| visually evoked potentials | 48 weeks and 56 weeks postconceptional age |
Secondary
| Measure | Time frame |
|---|---|
| intensity of endogenous conversion of essential fatty acids into long chain polyunsaturated fatty acids | 28 days after study start |
Countries
Germany
Outcome results
None listed