Nutrition and Neurological Development of Very Preterm Infants (EPINUTRI_3)
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|ClinicalTrials.gov Identifier: NCT02184650|
Recruitment Status : Completed
First Posted : July 9, 2014
Last Update Posted : August 28, 2018
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
|Condition or disease||Intervention/treatment|
|Premature Infant Infant Nutrition Disorders Delayed Mental Development||Other: Premature infants with a GA < 32 weeks|
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.
|Study Type :||Observational|
|Actual Enrollment :||206 participants|
|Official Title:||Early Nutrition and Neurological Development of Very Preterm Infants|
|Actual Study Start Date :||July 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||December 31, 2017|
Premature infants with a GA < 32 weeks
Other: Premature infants with a GA < 32 weeks
At 3 years of age: ASQ (filled in by parents)
- Neurological development [ Time Frame: At 3 years of age ]Age and Stages Questionnaire
Biospecimen Retention: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02184650
|Hôpital Necker Assistance Publique- Hôpitaux de Paris|
|Paris, France, 75015|
|Principal Investigator:||Alexandre Lapillonne, M.D, Ph.D.||Hôpital Necker Assistance Publique-Hôpitaux de Paris|