Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-02-10 @ 4:18 PM
Study NCT ID:
NCT02184650
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2014-07-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutrition and Neurological Development of Very Preterm Infants
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Early Nutrition and Neurological Development of Very Preterm Infants
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPINUTRI_3
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
* 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ID RCB 2014-A00941-46 | OTHER | France: Ministry of Health | View |