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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
December 13, 2011
December 15, 2011
September 20, 2017
October 25, 2011
April 2018   (Final data collection date for primary outcome measure)
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).
Not Provided
Complete list of historical versions of study NCT01493063 on ClinicalTrials.gov Archive Site
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)
Not Provided
  • 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
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Breastmilk samples et infant serum samples
Non-Probability Sample
Preterm newborn
Prematurity of Fetus
Other: Physiopathology
Samples of breastmilk and infant serum
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
160
April 2018
April 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
28 Weeks to 34 Weeks   (Child)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01493063
BRD/11/02-Y
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Nantes University Hospital
Nantes University Hospital
Not Provided
Principal Investigator: Cécile Boscher, Doctor CHU Nantes
Nantes University Hospital
September 2017