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

April 16, 2013 updated by: Alexandre Lapillonne, M.D., Ph.D., Lapillonne, Alexandre, M.D.

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Necker Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

Inclusion criteria:

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

Exclusion criteria:

  • death during hospitalisation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological development at 2 years of age
Time Frame: 3 years

Age and Stages Questionnaire at 2 years of age

Brunet Lezine test
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status at time of discharge
Time Frame: 1 year

Polyunsaturated fatty acids status

Iron status
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lapillonne, Alexandre, M.D.

Investigators

  • Study Director: Alexandre Lapillonne, M.D., Ph.D., Alexandre Lapillonne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

December 2, 2011

First Submitted That Met QC Criteria

December 5, 2011

First Posted (Estimate)

December 6, 2011

Study Record Updates

Last Update Posted (Estimate)

April 17, 2013

Last Update Submitted That Met QC Criteria

April 16, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-mars-12551

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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