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Clinical Trials/NCT02184650
NCT02184650
Completed
Not Applicable

Early Nutrition and Neurological Development of Very Preterm Infants

Assistance Publique - Hôpitaux de Paris1 site in 1 country206 target enrollmentJuly 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature Infant
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
206
Locations
1
Primary Endpoint
Neurological development
Status
Completed
Last Updated
5 months ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2014
End Date
December 31, 2017
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Neurological development

Time Frame: At 3 years of age

Age and Stages Questionnaire

Study Sites (1)

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