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

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Prematurity of Fetus

Treatments: Dietary Supplement: low docosahexaenoic acid formula; Dietary Supplement: breast milk; Dietary Supplement: medium docosahexaenoic acid formula; Dietary Supplement: high docosahexaenoic acid formula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01300130

45-95

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: Under 14 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 4 patient groups

low docosahexaenoic acid formula

Experimental group

Treatment:

Dietary Supplement: low docosahexaenoic acid formula

medium docosahexaenoic acid formula

Experimental group

Treatment:

Dietary Supplement: medium docosahexaenoic acid formula

high docosahexaenoic acid formula

Experimental group

Treatment:

Dietary Supplement: high docosahexaenoic acid formula

human milk

Active Comparator group

Treatment:

Dietary Supplement: breast milk