Overview

This trial is active, not recruiting.

Conditions premature infant, infant nutrition disorders, delayed mental development
Treatment premature infants with a ga < 32 weeks
Sponsor Assistance Publique - Hôpitaux de Paris
Start date July 2014
End date July 2015
Trial size 200 participants
Trial identifier NCT02184650, ID RCB 2014-A00941-46, NI 13016

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Premature infants with a GA < 32 weeks
premature infants with a ga < 32 weeks
At 3 years of age: ASQ (filled in by parents)

Primary Outcomes

Measure
Neurological development
time frame: At 3 years of age

Eligibility Criteria

Male or female participants from 3 years up to 3 years old.

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

Additional Information

Official title Early Nutrition and Neurological Development of Very Preterm Infants
Principal investigator Alexandre Lapillonne, M.D, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.