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Early Nutrition and Neurological Development of Very Preterm Infants (EPINUTRI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Alexandre Lapillonne, M.D., Ph.D., Lapillonne, Alexandre, M.D..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01486173
First Posted: December 6, 2011
Last Update Posted: April 17, 2013
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):
Alexandre Lapillonne, M.D., Ph.D., Lapillonne, Alexandre, M.D.
December 2, 2011
December 6, 2011
April 17, 2013
June 2011
December 2014   (Final data collection date for primary outcome measure)
Neurological development at 2 years of age [ Time Frame: 3 years ]

Age and Stages Questionnaire at 2 years of age

Brunet Lezine test

Same as current
Complete list of historical versions of study NCT01486173 on ClinicalTrials.gov Archive Site
Nutritional status at time of discharge [ Time Frame: 1 year ]

Polyunsaturated fatty acids status

Iron status

Same as current
Not Provided
Not Provided
 
Early Nutrition and Neurological Development of Very Preterm Infants
Early Nutrition and Neurological Development of Very Preterm Infants

The main goal of this study is to determine the association between:

  • the quantity of mother's milk and duration of breastfeeding
  • the intake of polyunsaturated fatty acids and iron during hospitalization and the development of preterm infants born with a GA < 32 weeks.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
whole blood
Non-Probability Sample
Subsample of infants born very preterm (before 32 weeks of gestation) otherwise included in the French national cohort EPIPAGE 2
  • Infant, Premature, Diseases
  • Infant Nutrition Disorders
  • Development; Delayed, Mental
Not Provided
  • Premature infants with a GA < 32 Weeks
  • New born with a GA > 37Weeks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
260
December 2014
December 2014   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • infants with a gestational age < 32 weeks already included in the EPIPAGE2 study
  • agreement of parents

Exclusion criteria:

  • death during hospitalisation
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01486173
2011-mars-12551
Yes
Not Provided
Not Provided
Alexandre Lapillonne, M.D., Ph.D., Lapillonne, Alexandre, M.D.
Lapillonne, Alexandre, M.D.
Not Provided
Study Director: Alexandre Lapillonne, M.D., Ph.D. Alexandre Lapillonne
Lapillonne, Alexandre, M.D.
April 2013