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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physiopathology | Other | Samples of breastmilk and infant serum and questionnaires. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the impact of the protein content of human milk on the Body composition (% fat/lean mass) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Preterm newborn
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| Name | Affiliation | Role |
|---|---|---|
| Cécile Boscher, Doctor | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Nantes | Nantes | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33929587 | Background | 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. | |
| 41544718 |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Breastmilk samples et infant serum samples
Dietary 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 | Staturo-weight growth rate | 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 | Standardized and validated test WISC V | 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 | Standardized and validated test FEE | At 7-8 years of age |
| To assess the impact of the protein content of human milk on the executive dysfunction of the preterm infant | Standardized and validated test BRIEF battery | At 7-8 years of age |
| To assess the impact of the protein content of human milk on the child's behaviour in the classroom of the preterm infant | Standardized and validated test GSA | At 7-8 years of age |
| To assess the impact of the protein content of human milk on the generalist clinical evaluation of the preterm infant | Standardized and validated test BMT-i | At 7-8 years of age |
| To assess the impact of the protein content of human milk on the physical activity of the preterm infant | Actimeter (ACTIGRAPH®) | At 7-8 years of age |
| To assess the impact of the protein content of human milk on the physical activity of the preterm infant | ESTEBAN questionnaire (Santé Publique France). | At 7-8 years of age |
| 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 | Level 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, oligosaccharides | Correlation obtained between nutritional data from breast milk and identified metabolic markers in children. |
| Ancillary study N°4. Relationship between breast milk nutritional data and clinical data of mother-child dyads. | Correlation obtained between the data. |
| Ancillary study N°5. Correlation between breast milk protein concentration and neurological development at 7-8 years of age. | Correlation between breast milk protein concentration and neurological development at 7-8 years of age. | At 7-8 years of age |
| Ancillary study N°6. Equation for estimating fat mass (percentage) in children with the new version of the Biody Xpert device from Aminogram. | Validation of an equation for estimating fat mass (percentage) in children with the new version of the Biody Xpert device from Aminogram, using a BodPod measurement as reference. |
| Ancillary study N°7. Equation for estimating lean mass (percentage) in children with the new version of the Biody Xpert device from Aminogram. | Validation of an equation for estimating lean mass (percentage) in children with the new version of the Biody Xpert device from Aminogram, using a BodPod measurement as reference. |
| 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. |
| D000091642 | Urogenital Diseases |