NCT02503020|CompletedPhase 2
Arachidonic Acid Supplementation in Very Preterm Infants
Effects of Different Arachidonic Acid Supplementation on Psychomotor Development in Very Preterm Infants, a Randomized Controlled Trial
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Effects of Different Arachidonic Acid Supplementation on Psychomotor Development in Very Preterm Infants, a Randomized Controlled Trial
Sponsor study identifier
interventional
45
0 countries
N/A
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2014
Actual (reported)Study Completion
March 2015
Actual (reported)Long-chain polyunsaturated fatty acids (LCPUFAs), arachidonic acid (AA omega-6; 20:4ω-6), and docosahexaenoic acid (DHA omega-3; 22:6ω-3), are required for the formation of non-myelinated cell membranes in the central nervous system, including in the retina, hence the great importance of them for appropriate visual and cognitive development. In this study, the investigators assessed anthropometric, visual, auditory, and psychomotor development in very preterm infants who had diets supplemented with different LCPUFA amount of AA to support the importance of sufficient AA values in formula.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
November 2014
Actual (reported)March 2015
Actual (reported)July 14, 2015
Actual (reported)July 20, 2015
Actual (reported)Psychomotor development
Evaluation of psychomotor development by making Brunet-Lezine scale at 2 years of corrected age.
From september 2013 to november 2014 (at two years of corrected age)
Levels of fatty acids in plasma
From october 2011 to november 2013 (from 3 months to 1 years old)
Visual- and auditory-evoked potentials
From january 2012 to February 2013 (from 6 months to 1 years old)
Weight
From october 2011 to november 2014 (from 6 months to 2 years old)
Length
From october 2011 to november 2014 (from 6 months to 2 years old)
Head circumference
From october 2011 to november 2014 (from 6 months to 2 years old)
Preterm infants formula A Pretarm infants were fed on formula with Arachidonic acid (0.6%) and Docosahexaenoic acid (0.3%)
Preterm infants formula B Pretarm infants were fed on formula with Arachidonic acid (0.3%) and Docosahexaenoic acid (0.3%)
Group A will receive a preterm infants formula supplemented with AA (0.6%) and DHA (0.3%) until they have three months corrected age. At 3 and 6 months of corrected age, we changed the type of milk according to the nutritional requirements, but maintained the same ratio of AA and DHA (2/1) until one year corrected age.
Group B will receive other Preterm infants formula very similar, but with AA (0.3%) and DHA (0.3%) also until they have three months corrected age. At 3 and 6 months of corrected age, we changed the type of milk according to the nutritional requirements, but maintained the same ratio of AA and DHA (1/1) until one year corrected age.
Alshweki A, Munuzuri AP, Bana AM, de Castro MJ, Andrade F, Aldamiz-Echevarria L, de Pipaon MS, Fraga JM, Couce ML. Effects of different arachidonic acid supplementation on psychomotor development in very preterm infants; a randomized controlled trial. Nutr J. 2015 Sep 30;14:101. doi: 10.1186/s12937-015-0091-3.
45 participants (actual enrollment reported by the registry).
First Submitted
July 14, 2015
First Posted
July 20, 2015
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
November 2014
Actual (reported)Study Completion
March 2015
Actual (reported)Last Updated
July 20, 2015
Record last verified: 2015-07
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Source: ClinicalTrials.gov.
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