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

Active, not recruiting

• Conditions: Prematurity of Fetus

• Registration Number: NCT01493063
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-25
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2011-12-14
• Study First Posted: 2011-12-15
• Primary Completion: 2018-04
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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).

Secondary Outcome Measures

Name	Time	Method
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	Standardized and validated test FEE
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	Standardized and validated test WISC V
To assess the impact of the protein content of human milk on the executive dysfunction of the preterm infant	At 7-8 years of age	Standardized and validated test BRIEF battery
To assess the impact of the protein content of human milk on the child's behaviour in the classroom of the preterm infant	At 7-8 years of age	Standardized and validated test GSA
To assess the impact of the protein content of human milk on the generalist clinical evaluation of the preterm infant	At 7-8 years of age	Standardized and validated test BMT-i
To assess the impact of the protein content of human milk on the physical activity of the preterm infant	At 7-8 years of age	ESTEBAN questionnaire (Santé Publique France).
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	Body composition (% fat/lean mass)
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	Dietary behavior
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	Staturo-weight growth rate

Trial Locations

Locations (1)

University Hospital of Nantes; 🇫🇷 Nantes, France