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

Prematurity of Fetus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01493063
• Other study ID #: BRD/11/02-Y
• Status: Active, not recruiting
• Start date: October 25, 2011
• Est. completion date: September 2025

Study information

• Verified date: May 2023
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: September 2025
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 34 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Prematurity of Fetus

Intervention

Other:
• Physiopathology
Samples of breastmilk and infant serum and questionnaires.

Locations

Country	Name	City	State
France	University Hospital of Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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.
Other	Ancillary study N°4. Relationship between breast milk nutritional data and clinical data of mother-child dyads.	Correlation obtained between the data.
Other	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
Other	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.
Other	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.
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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