Investigations on Improving Docosahexaenoic and Arachidonic Acid Content in Preterm Infant Formula
Primary Purpose
Prematurity of Fetus
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
low docosahexaenoic acid formula
medium docosahexaenoic acid formula
high docosahexaenoic acid formula
breast milk
Sponsored by

About this trial
This is an interventional supportive care trial for Prematurity of Fetus focused on measuring neurological development, preterm infants, fatty acid status
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
Sites / Locations
- Children´s Hospital, Zentralklinikum Augsburg
- Josephinum Hospital
- I. Frauenklinik of the Ludwig-Maximilians-University
- Lachnerklinik
- University Hospital Rechts der Isar
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
low docosahexaenoic acid formula
medium docosahexaenoic acid formula
high docosahexaenoic acid formula
human milk
Arm Description
Outcomes
Primary Outcome Measures
plasma phospholipid fatty acid composition
visually evoked potentials
Secondary Outcome Measures
intensity of endogenous conversion of essential fatty acids into long chain polyunsaturated fatty acids
Full Information
NCT ID
NCT01300130
First Posted
February 18, 2011
Last Updated
February 18, 2011
Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Société des Produits Nestlé (SPN), German Federal Ministry of Education and Research, German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01300130
Brief Title
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
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
June 1995 (undefined)
Primary Completion Date
March 1998 (Actual)
Study Completion Date
March 1998 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Société des Produits Nestlé (SPN), German Federal Ministry of Education and Research, German Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity of Fetus
Keywords
neurological development, preterm infants, fatty acid status
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low docosahexaenoic acid formula
Arm Type
Experimental
Arm Title
medium docosahexaenoic acid formula
Arm Type
Experimental
Arm Title
high docosahexaenoic acid formula
Arm Type
Experimental
Arm Title
human milk
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
low docosahexaenoic acid formula
Intervention Type
Dietary Supplement
Intervention Name(s)
medium docosahexaenoic acid formula
Intervention Type
Dietary Supplement
Intervention Name(s)
high docosahexaenoic acid formula
Intervention Type
Dietary Supplement
Intervention Name(s)
breast milk
Intervention Description
a non randomized group of breast milk fed infants was included
Primary Outcome Measure Information:
Title
plasma phospholipid fatty acid composition
Time Frame
28 days after intervention start
Title
visually evoked potentials
Time Frame
48 weeks and 56 weeks postconceptional age
Secondary Outcome Measure Information:
Title
intensity of endogenous conversion of essential fatty acids into long chain polyunsaturated fatty acids
Time Frame
28 days after study start
10. Eligibility
Sex
All
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Koletzko, Prof.
Organizational Affiliation
Ludwig-Maximilians - University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children´s Hospital, Zentralklinikum Augsburg
City
Augsburg
Country
Germany
Facility Name
Josephinum Hospital
City
Augsburg
Country
Germany
Facility Name
I. Frauenklinik of the Ludwig-Maximilians-University
City
München
Country
Germany
Facility Name
Lachnerklinik
City
München
Country
Germany
Facility Name
University Hospital Rechts der Isar
City
München
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
22008957
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.
Results Reference
derived
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Investigations on Improving Docosahexaenoic and Arachidonic Acid Content in Preterm Infant Formula
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