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

NCT01493063 | Unknown

• 1 other identifier: BRD/11/02-Y
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity of Fetus

Keywords

preterm infant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (7)

• 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.

• 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

• 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

Interventions

Physiopathology OTHER

Samples of breastmilk and infant serum and questionnaires.

Eligibility Criteria

• Age: 28 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm newborn

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

University Hospital of Nantes

Nantes, France

Location

Related Publications (2)

• 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.

  PMID: 33929587 BACKGROUND

• Alexandre-Gouabau MC, Moyon T, Douarec C, Moulazem Y, Croyal M, Gourdel M, Roze JC, Simon L, Boscher C, Billard H, David-Sochard A, Reze S, Misery B, Bizec BL, Guillou S, Antignac JP, Boquien CY, Vigneau E, Mahieu B, Cano-Sancho G. An Exploration of the Breast Milk Nutriome, Exposome and Microbiome and their Links to Early Growth in Preterm Infants. J Nutr Biochem. 2026 Jan 14:110268. doi: 10.1016/j.jnutbio.2026.110268. Online ahead of print.

  PMID: 41544718 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Breastmilk samples et infant serum samples

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Cécile Boscher, Doctor

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 15, 2011
• Study Start: October 25, 2011
• Primary Completion: April 1, 2018
• Study Completion: September 1, 2025
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

FR (1)