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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2013 by Lapillonne, Alexandre, M.D..
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Alexandre Lapillonne, M.D., Ph.D., Lapillonne, Alexandre, M.D.
ClinicalTrials.gov Identifier:
First received: December 2, 2011
Last updated: April 16, 2013
Last verified: April 2013

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.

Infant, Premature, Diseases
Infant Nutrition Disorders
Development; Delayed, Mental

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Nutrition and Neurological Development of Very Preterm Infants

Resource links provided by NLM:

Further study details as provided by Lapillonne, Alexandre, M.D.:

Primary Outcome Measures:
  • Neurological development at 2 years of age [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    Age and Stages Questionnaire at 2 years of age

    Brunet Lezine test

Secondary Outcome Measures:
  • Nutritional status at time of discharge [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Polyunsaturated fatty acids status

    Iron status

Biospecimen Retention:   Samples With DNA

whole blood

Estimated Enrollment: 260
Study Start Date: June 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Premature infants with a GA < 32 Weeks
New born with a GA > 37Weeks


Genders Eligible for Study:   Both
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


Inclusion criteria:

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

Exclusion criteria:

  • death during hospitalisation
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01486173

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

No publications provided

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
Study First Received: December 2, 2011
Last Updated: April 16, 2013
Health Authority: France: The Commission nationale de l’informatique et des libertés
France: Committee for the Protection of Personnes
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

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

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

ClinicalTrials.gov processed this record on October 13, 2015