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

May 9, 2023 updated by: Nantes University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • University Hospital of Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess the impact of the protein content of human milk on the Body composition (% fat/lean mass)
Time Frame: At 2 years of age and at 7-8 years of age
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
Time Frame: At 2 years of age and at 7-8 years of age
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
Time Frame: At 2 years of age and at 7-8 years of age
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
Time Frame: At 7-8 years of age
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
Time Frame: At 7-8 years of age
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
Time Frame: At 7-8 years of age
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
Time Frame: At 7-8 years of age
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
Time Frame: At 7-8 years of age
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
Time Frame: At 7-8 years of age
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
Time Frame: At 7-8 years of age
ESTEBAN questionnaire (Santé Publique France).
At 7-8 years of age

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cécile Boscher, Doctor, CHU Nantes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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