LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns

Study Overview
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Brief Summary
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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.

Official Title
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BRD/11/02-Y LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns.

Conditions
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Prematurity of Fetus

Intervention / Treatment
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* Other: Physiopathology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Maternal decision of breastfeeding Born between 28 and 34 weeks of amenorrhea No important congenital pathology except prematurity Efficiency of the breastfeeding compatible with the research by the investigator Information and authorization of the parents or the parental authority Exclusion Criteria: Maternal decision of not breastfeeding Born before 28 weeks of amenorrhoea or after or at 34 weeks of amenorrhoea Important congenital pathology Efficiency of the breastfeeding incompatible with the research by the investigator Opposition from parents or the parental authority to participate to the research study

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Physiopathology|Samples of breastmilk and infant serum and questionnaires.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm infant