Clinical trial NCT01300130: Investigations on Improving Docosahexaenoic and Arachidonic Acid Content in Preterm Infant Formula
Official title: Investigations on Improving Docosahexaenoic and Arachidonic Acid Content in Preterm Infant Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity of Fetus
Keywords: neurological development
preterm infants
fatty acid status
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Société des Produits Nestlé (SPN)
name: German Federal Ministry of Education and Research
name: German Research Foundation
First posted: 2011-02-21
Enrollment: 66
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: plasma phospholipid fatty acid composition
timeFrame: 28 days after intervention start
measure: visually evoked potentials
timeFrame: 48 weeks and 56 weeks postconceptional age
Secondary outcomes:
measure: intensity of endogenous conversion of essential fatty acids into long chain polyunsaturated fatty acids
timeFrame: 28 days after study start
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Children´s Hospital, Zentralklinikum Augsburg
city: Augsburg
country: Germany
facility: Josephinum Hospital
city: München
country: Germany
facility: I. Frauenklinik of the Ludwig-Maximilians-University
city: München
country: Germany
facility: Lachnerklinik
city: München
country: Germany
facility: University Hospital Rechts der Isar
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Berthold Koletzko, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sauerwald UC, Fink MM, Demmelmair H, Schoenaich PV, Rauh-Pfeiffer AA, Koletzko B. Effect of different levels of docosahexaenoic acid supply on fatty acid status and linoleic and alpha-linolenic acid conversion in preterm infants. J Pediatr Gastroenterol Nutr. 2012 Mar;54(3):353-63. doi: 10.1097/MPG.0b013e31823c3bfd.