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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01493063
First received: December 13, 2011
Last updated: May 3, 2016
Last verified: April 2016

December 13, 2011
May 3, 2016
September 2011
March 2016   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01493063 on ClinicalTrials.gov Archive Site
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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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Preterm newborn
Prematurity of Fetus
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
156
January 2018
March 2016   (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
Both
28 Weeks to 34 Weeks   (Child)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01493063
BRD/11/02-Y
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Nantes University Hospital
Nantes University Hospital
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Principal Investigator: Cécile Boscher, Doctor CHU Nantes
Nantes University Hospital
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP