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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Malnutrition
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on July 31, 2014