Investigations on Improving Docosahexaenoic and Arachidonic Acid Content in Preterm Infant Formula
NCT ID: NCT01300130
Last Updated: 2011-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
1995-06-30
1998-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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low docosahexaenoic acid formula
low docosahexaenoic acid formula
medium docosahexaenoic acid formula
medium docosahexaenoic acid formula
high docosahexaenoic acid formula
high docosahexaenoic acid formula
human milk
breast milk
a non randomized group of breast milk fed infants was included
Interventions
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low docosahexaenoic acid formula
medium docosahexaenoic acid formula
high docosahexaenoic acid formula
breast milk
a non randomized group of breast milk fed infants was included
Eligibility Criteria
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Inclusion Criteria
* birth weight between 1000 and 2200 g
* more than 80 % of energy intake from infant formula or human milk at enrollment
Exclusion Criteria
* 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
14 Days
ALL
No
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
German Federal Ministry of Education and Research
OTHER_GOV
German Research Foundation
OTHER
Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
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Ludwig-Maximilians - University of Munich
Principal Investigators
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Berthold Koletzko, Prof.
Role: PRINCIPAL_INVESTIGATOR
Ludwig-Maximilians - University of Munich
Locations
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Children´s Hospital, Zentralklinikum Augsburg
Augsburg, , Germany
Josephinum Hospital
Augsburg, , Germany
I. Frauenklinik of the Ludwig-Maximilians-University
München, , Germany
Lachnerklinik
München, , Germany
University Hospital Rechts der Isar
München, , Germany
Countries
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References
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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.
Other Identifiers
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45-95
Identifier Type: -
Identifier Source: org_study_id
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