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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01300130
First Posted: February 21, 2011
Last Update Posted: February 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Nestlé
German Federal Ministry of Education and Research
German Research Foundation
Information provided by:
Ludwig-Maximilians - University of Munich
  Purpose

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.


Condition Intervention
Prematurity of Fetus Dietary Supplement: low docosahexaenoic acid formula Dietary Supplement: medium docosahexaenoic acid formula Dietary Supplement: high docosahexaenoic acid formula Dietary Supplement: breast milk

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Investigations on Improving Docosahexaenoic and Arachidonic Acid Content in Preterm Infant Formula

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • plasma phospholipid fatty acid composition [ Time Frame: 28 days after intervention start ]
  • visually evoked potentials [ Time Frame: 48 weeks and 56 weeks postconceptional age ]

Secondary Outcome Measures:
  • intensity of endogenous conversion of essential fatty acids into long chain polyunsaturated fatty acids [ Time Frame: 28 days after study start ]

Enrollment: 66
Study Start Date: June 1995
Study Completion Date: March 1998
Primary Completion Date: March 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: low docosahexaenoic acid formula Dietary Supplement: low docosahexaenoic acid formula
Experimental: medium docosahexaenoic acid formula Dietary Supplement: medium docosahexaenoic acid formula
Experimental: high docosahexaenoic acid formula Dietary Supplement: high docosahexaenoic acid formula
Active Comparator: human milk Dietary Supplement: breast milk
a non randomized group of breast milk fed infants was included

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300130


Locations
Germany
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
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Nestlé
German Federal Ministry of Education and Research
German Research Foundation
Investigators
Principal Investigator: Berthold Koletzko, Prof. Ludwig-Maximilians - University of Munich
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01300130     History of Changes
Other Study ID Numbers: 45-95
First Submitted: February 18, 2011
First Posted: February 21, 2011
Last Update Posted: February 21, 2011
Last Verified: February 2011

Keywords provided by Ludwig-Maximilians - University of Munich:
neurological development
preterm infants
fatty acid status