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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prematurity of Fetus
• Intervention / Treatment: Other: Physiopathology

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • University Hospital of Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 months (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Preterm newborn

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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
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.

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Cécile Boscher, Doctor, CHU Nantes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2011
• Primary Completion (Actual): April 1, 2018
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: December 13, 2011
• First Submitted That Met QC Criteria: December 14, 2011
• First Posted (Estimate): December 15, 2011

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: preterm infant
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: BRD/11/02-Y

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No