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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01493063
First Posted: December 15, 2011
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nantes University Hospital
  Purpose

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.


Condition Intervention
Prematurity of Fetus Other: Physiopathology

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: BRD/11/02-Y "LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns".

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • To assess the impact of the protein content of human milk on the Body composition (%FAT MASS) and growth trajectory of the Preterm infant (from 0 to 2 years) [ Time Frame: End of hospitalization and at 2 years of age. ]
    • Body composition (%Fat mass) at the end of hospitalization
    • Growth trajectory of the Preterm infant (from 0 to 2)


Other Outcome Measures:
  • 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;linking biological data and clinical data of mother and infant dyads
    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
    Biomarkers identified in both biological materials (breastmilk and infant serum)

  • Ancillary study N°4. Study of the digested human milk during the first few weeks of life of the preterm infant
    Composition in proteins and peptides of breastmilk before and after digestion by the infant


Biospecimen Retention:   Samples With DNA
Breastmilk samples et infant serum samples

Enrollment: 160
Actual Study Start Date: October 25, 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Physiopathology
    Samples of breastmilk and infant serum
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   28 Weeks to 34 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Preterm newborn
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493063


Locations
France
University Hospital of Nantes
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Cécile Boscher, Doctor CHU Nantes
  More Information

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01493063     History of Changes
Other Study ID Numbers: BRD/11/02-Y
First Submitted: December 13, 2011
First Posted: December 15, 2011
Last Update Posted: September 20, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nantes University Hospital:
preterm infant