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Completed

NCT Number: NCT02184650

Nutrition and Neurological Development of Very Preterm Infants

The main goal of this study is to determine, in preterm infants born with a GA < 32 weeks, the association between:

* the quantity of mother's milk and duration and breastfeeding * the intake of polyunsaturated fatty acids and iron during hospitalizations

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Key information

Conditions

Premature Infant Delayed Mental Development Female Urogenital Diseases and Pregnancy Complications Infant Nutrition Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

3 year–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Necker Assistance Publique- Hôpitaux de Paris

Paris, 75015, France

About this study

The main hypothesis of this study is that the intake of lipid during hospitalization in neonatology department is associated with neurological development of preterm infants born with a GA < 32 weeks. The other hypotheses are that iron intake and the duration of breastfeeding are also associated with the development of preterm infants.

In the previous study EPINUTRI (NCT01486173), the development of infants was evaluated until the age of 1 year. EPINUTRI_3 is the follow-up of EPINUTRI until the age of 3 years.

The aim of EPINUTRI_3 study is to determine the association between lipid intake during hospitalization in neonatology department of preterm infants born with a GA < 32 weeks.

The secondary objective is :

  • to evaluate the association between these factors and communication, developmental and social-emotional delays with the test " Ages and Stages questionnaire " (ASQ) at 3 years of age.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premature infants previously included in EPINUTRI study
  • Non opposition of the parents for the collection of clinical and nutritional data

Exclusion criteria

  • Refusal of the parents to collect clinical and nutritional data

Treatment and study plan

Premature infants with a GA < 32 weeks

Other

At 3 years of age: ASQ (filled in by parents)

Primary outcomes

  1. Neurological development

    Time frame: At 3 years of age

    Age and Stages Questionnaire

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Early Nutrition and Neurological Development of Very Preterm Infants

Acronym: EPINUTRI_3

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Jul 9, 2014
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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