Investigations on Improving Docosahexaenoic and Arachidonic Acid Content in Preterm Infant Formula

Study Overview
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Brief Summary
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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.

Official Title
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Investigations on Improving Docosahexaenoic and Arachidonic Acid Content in Preterm Infant Formula

Conditions
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Prematurity of Fetus

Intervention / Treatment
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* Dietary Supplement: low docosahexaenoic acid formula
* Dietary Supplement: medium docosahexaenoic acid formula
* Dietary Supplement: high docosahexaenoic acid formula
* Dietary Supplement: breast milk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low docosahexaenoic acid formula<br> | Dietary Supplement: low docosahexaenoic acid formula<br> <br> |
| Experimental: medium docosahexaenoic acid formula<br> | Dietary Supplement: medium docosahexaenoic acid formula<br> <br> |
| Experimental: high docosahexaenoic acid formula<br> | Dietary Supplement: high docosahexaenoic acid formula<br> <br> |
| Active Comparator: human milk<br> | Dietary Supplement: breast milk<br>* a non randomized group of breast milk fed infants was included<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma phospholipid fatty acid composition |  | 28 days after intervention start | 
| visually evoked potentials |  | 48 weeks and 56 weeks postconceptional age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intensity of endogenous conversion of essential fatty acids into long chain polyunsaturated fatty acids |  | 28 days after study start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurological development, preterm infants, fatty acid status