Clinical trial NCT01493063: LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns
Official title: BRD/11/02-Y "LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns".
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prematurity of Fetus
Keywords: preterm infant
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2011-12-15
Enrollment: 160
Sex: ALL
Minimum age (years): 28
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm newborn

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: At 2 years of age
Secondary outcomes:
measure: To assess the impact of the protein content of human milk on the Body composition (% fat/lean mass)
timeFrame: At 2 years of age and at 7-8 years of age
measure: To assess the impact of the protein content of human milk on feeding behavior
timeFrame: At 2 years of age and at 7-8 years of age
measure: To assess the impact of the protein content of human milk on growth trajectory and metabolic status of the preterm infant
timeFrame: At 2 years of age and at 7-8 years of age
measure: To assess the impact of the protein content of human milk on the coginitive intelligence of the preterm infant
timeFrame: At 7-8 years of age
measure: To assess the impact of the protein content of human milk on the executive functioning of the preterm infant
timeFrame: At 7-8 years of age
measure: To assess the impact of the protein content of human milk on the executive dysfunction of the preterm infant
timeFrame: At 7-8 years of age
measure: To assess the impact of the protein content of human milk on the child's behaviour in the classroom of the preterm infant
timeFrame: At 7-8 years of age
measure: To assess the impact of the protein content of human milk on the generalist clinical evaluation of the preterm infant
timeFrame: At 7-8 years of age
measure: To assess the impact of the protein content of human milk on the physical activity of the preterm infant
timeFrame: At 7-8 years of age
measure: To assess the impact of the protein content of human milk on the physical activity of the preterm infant
timeFrame: At 7-8 years of age
Other outcomes:
measure: 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.
measure: 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
measure: 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
measure: Ancillary study N°4. Relationship between breast milk nutritional data and clinical data of mother-child dyads.
measure: Ancillary study N°5. Correlation between breast milk protein concentration and neurological development at 7-8 years of age.
timeFrame: At 7-8 years of age
measure: Ancillary study N°6. Equation for estimating fat mass (percentage) in children with the new version of the Biody Xpert device from Aminogram.
measure: Ancillary study N°7. Equation for estimating lean mass (percentage) in children with the new version of the Biody Xpert device from Aminogram.
Locations:
city: Nantes
country: France
facility: University Hospital of Nantes
Study officials:
affiliation: Nantes University Hospital
name: Cécile Boscher, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.