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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01493063
First received: December 13, 2011
Last updated: September 9, 2014
Last verified: September 2014
  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
Prematurity of Fetus

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:

Estimated Enrollment: 156
Study Start Date: September 2011
  Eligibility

Ages Eligible for Study:   28 Weeks to 34 Weeks
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493063

Locations
France
University Hospital of Nantes Recruiting
Nantes, France
Contact: Cécile BOSCHER, Doctor    +33 2 40 08 76 80    cecile.boscher@chu-nantes.fr   
Principal Investigator: Cécile Boscher, Doctor         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Cécile Boscher, Doctor CHU Nantes
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01493063     History of Changes
Other Study ID Numbers: 11/02-Y
Study First Received: December 13, 2011
Last Updated: September 9, 2014
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Nantes University Hospital:
preterm newborns

ClinicalTrials.gov processed this record on October 19, 2014