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

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ClinicalTrials.gov Identifier: NCT01486173
Recruitment Status : Unknown
Verified April 2013 by Alexandre Lapillonne, M.D., Ph.D., Lapillonne, Alexandre, M.D..
Recruitment status was:  Active, not recruiting
First Posted : December 6, 2011
Last Update Posted : April 17, 2013
Sponsor:
Information provided by (Responsible Party):
Alexandre Lapillonne, M.D., Ph.D., Lapillonne, Alexandre, M.D.

Brief Summary:

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.

Condition or disease
Infant, Premature, Diseases Infant Nutrition Disorders Development; Delayed, Mental

Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Nutrition and Neurological Development of Very Preterm Infants
Study Start Date : June 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Group/Cohort
Premature infants with a GA < 32 Weeks
New born with a GA > 37Weeks



Primary Outcome Measures :
  1. Neurological development at 2 years of age [ Time Frame: 3 years ]

    Age and Stages Questionnaire at 2 years of age

    Brunet Lezine test



Secondary Outcome Measures :
  1. Nutritional status at time of discharge [ Time Frame: 1 year ]

    Polyunsaturated fatty acids status

    Iron status



Biospecimen Retention:   Samples With DNA
whole blood


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subsample of infants born very preterm (before 32 weeks of gestation) otherwise included in the French national cohort EPIPAGE 2
Criteria

Inclusion criteria:

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

Exclusion criteria:

  • death during hospitalisation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01486173


Locations
France
Necker hospital
Paris, Ile-de-France, France, 75014
Sponsors and Collaborators
Lapillonne, Alexandre, M.D.
Investigators
Study Director: Alexandre Lapillonne, M.D., Ph.D. Alexandre Lapillonne

Responsible Party: Alexandre Lapillonne, M.D., Ph.D., Professor of Pediatrics, Lapillonne, Alexandre, M.D.
ClinicalTrials.gov Identifier: NCT01486173     History of Changes
Other Study ID Numbers: 2011-mars-12551
First Posted: December 6, 2011    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013

Keywords provided by Alexandre Lapillonne, M.D., Ph.D., Lapillonne, Alexandre, M.D.:
PUFA
Iron
Neurological development
Premature infant

Additional relevant MeSH terms:
Nutrition Disorders
Infant, Premature, Diseases
Infant Nutrition Disorders
Infant, Newborn, Diseases