LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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 [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).
Secondary Outcome Measures
- 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]
Body composition (% fat/lean mass)
- 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]
Dietary behavior
- 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]
Staturo-weight growth rate
- 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]
Standardized and validated test WISC V
- 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]
Standardized and validated test FEE
- To assess the impact of the protein content of human milk on the executive dysfunction of the preterm infant [At 7-8 years of age]
Standardized and validated test BRIEF battery
- To assess the impact of the protein content of human milk on the child's behaviour in the classroom of the preterm infant [At 7-8 years of age]
Standardized and validated test GSA
- To assess the impact of the protein content of human milk on the generalist clinical evaluation of the preterm infant [At 7-8 years of age]
Standardized and validated test BMT-i
Other Outcome Measures
- 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 []
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. [At 7-8 years of age]
Correlation between breast milk protein concentration and neurological development 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Maternal decision of breastfeeding
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Born between 28 and 34 weeks of amenorrhea
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No important congenital pathology except prematurity
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Efficiency of the breastfeeding compatible with the research by the investigator
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Information and authorization of the parents or the parental authority
Exclusion Criteria:
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Maternal decision of not breastfeeding
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Born before 28 weeks of amenorrhoea or after or at 34 weeks of amenorrhoea
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Important congenital pathology
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Efficiency of the breastfeeding incompatible with the research by the investigator
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Opposition from parents or the parental authority to participate to the research study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital of Nantes | Nantes | France |
Sponsors and Collaborators
- Nantes University Hospital
Investigators
- Principal Investigator: Cécile Boscher, Doctor, CHU Nantes
Study Documents (Full-Text)
None provided.More Information
Publications
- BRD/11/02-Y