This trial is active, not recruiting.

Condition prematurity of fetus
Sponsor Nantes University Hospital
Start date September 2011
End date March 2016
Trial size 156 participants
Trial identifier NCT01493063, BRD/11/02-Y


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Eligibility Criteria

Male or female participants from 28 weeks up to 34 weeks old.

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

Additional Information

Official title BRD/11/02-Y "LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns".
Principal investigator Cécile Boscher, Doctor
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Nantes University Hospital.