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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alexandre Lapillonne, M.D., Ph.D., Lapillonne, Alexandre, M.D.
ClinicalTrials.gov Identifier:
NCT01486173
First received: December 2, 2011
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  Purpose

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
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:

U.S. FDA Resources

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)
Groups/Cohorts
Premature infants with a GA < 32 Weeks
New born with a GA > 37Weeks

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  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.:
PUFA
Iron
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 June 17, 2013