LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||BRD/11/02-Y "LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns".|
- 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 [ Time Frame: 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).
- To assess the impact of the protein content of human milk on the Body composition (%FAT MASS) and growth trajectory of the Preterm infant (from 0 to 2 years) [ Time Frame: End of hospitalization and at 2 years of age. ]
- Body composition (%Fat mass) at the end of hospitalization
- Growth trajectory of the Preterm infant (from 0 to 2)
- 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.Association criterion between nutritional composition of human milk assessed by content determination of macro- and micronutrients, and omics approaches (metabolomics,…) and FFQ score
- 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;linking biological data and clinical data of mother and infant dyadsLevel of chemical contamination of the human milk
- 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, oligosaccharidesBiomarkers identified in both biological materials (breastmilk and infant serum)
- Ancillary study N°4. Study of the digested human milk during the first few weeks of life of the preterm infantComposition in proteins and peptides of breastmilk before and after digestion by the infant
Biospecimen Retention: Samples With DNA
|Actual Study Start Date:||October 25, 2011|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||April 2018 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493063
|University Hospital of Nantes|
|Principal Investigator:||Cécile Boscher, Doctor||CHU Nantes|