NCT01493063|Unknown
LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns
BRD/11/02-Y "LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns".
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BRD/11/02-Y "LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns".
Sponsor study identifier
observational
160
1 country
1
Study Start
October 25, 2011
Actual (reported)Primary Completion
April 2018
Actual (reported)Study Completion
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The aim of the study is to estimate the impact of the protein content of breastmilk at the end of hospitalization of the preterm newborn, on the neurodevelopment at 2 years old. The investigators expect a difference of at least 5 points of Development Quotient (DQ) when comparing extreme terciles of the protein content of breastmilk at the end of hospitalization.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 25, 2011
Actual (reported)December 13, 2011
Actual (reported)December 15, 2011
Actual (reported)April 2018
Actual (reported)September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To assess the impact of the protein content of human milk on the neuro-motor development of the preterm infant at 2 years of age
ASQ (Ages and Stages Questionnaires) score at 2 years of age. The calculation of the sample size is only based on this endpoint. We wish to highlight a difference of at least 25 points of the ASQ score between both extreme terciles of protein concentration determined in breast milk at the end of hospitalization, when breastfeeding is exclusive (last sample of breastmilk before the end of hospitalization).
At 2 years of age
To assess the impact of the protein content of human milk on the Body composition (% fat/lean mass)
At 2 years of age and at 7-8 years of age
To assess the impact of the protein content of human milk on feeding behavior
At 2 years of age and at 7-8 years of age
To assess the impact of the protein content of human milk on growth trajectory and metabolic status of the preterm infant
At 2 years of age and at 7-8 years of age
To assess the impact of the protein content of human milk on the coginitive intelligence of the preterm infant
At 7-8 years of age
To assess the impact of the protein content of human milk on the executive functioning of the preterm infant
At 7-8 years of age
Ancillary study 1.To assess the association between maternal eating habits(food intake during lactation estimated using the Food Frequency Questionnaire from the National French birth cohort ELFE), and the nutritional composition of human milk.
Ancillary study 2.To assess the chemical safety of human milk:identification of nutritional and environmental factors that could explain the presence of chemical contaminants
Ancillary study N°3. Composition of breast milk and preterm infant's metabolic status and growth trajectory during the first weeks of life. Biomarkers identified in breastmilk and infant serum: lipidome, metabolome, miRNome, amino acids, oligosaccharides
Samples of breastmilk and infant serum and questionnaires.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Preterm newborn
University Hospital of Nantes
Nantes, France
Boquien CY, Billard H, Simon L, Boscher C, Legrand A, Joram E, Moyon T, Alexandre-Gouabau MC, Darmaun D, Roze JC. Breast milk protein content at week 3 after birth and neurodevelopmental outcome in preterm infants fed fortified breast milk. Eur J Nutr. 2021 Oct;60(7):3959-3969. doi: 10.1007/s00394-021-02562-8. Epub 2021 Apr 30.
Alexandre-Gouabau MC, Moyon T, Douarec C, Moulazem Y, Croyal M, Gourdel M, Roze JC, Simon L, Boscher C, Billard H, David-Sochard A, Reze S, Misery B, Bizec BL, Guillou S, Antignac JP, Boquien CY, Vigneau E, Mahieu B, Cano-Sancho G. An exploration of the breast milk nutriome, exposome and microbiome and their links to early growth in preterm infants. J Nutr Biochem. 2026 May;151:110268. doi: 10.1016/j.jnutbio.2026.110268. Epub 2026 Jan 14.
Breastmilk samples et infant serum samples
Cécile Boscher, Doctor
Nantes University Hospital
160 participants (actual enrollment reported by the registry).
First Submitted
December 13, 2011
First Posted
December 15, 2011
Study Start
October 25, 2011
Actual (reported)Investigations on Improving Docosahexaenoic and Arachidonic Acid Content in Preterm Infant Formula
Contact the study team to confirm eligibility.
Primary Completion
April 2018
Actual (reported)Study Completion
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 10, 2023
Record last verified: 2023-05
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Source: ClinicalTrials.gov.
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