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NCT02184650 Clinical Trial

Nutrition and Neurological Development of Very Preterm Infants

Premature Infant Clinical Trial

— EPINUTRI_3  

Official title:
Early Nutrition and Neurological Development of Very Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02184650
Other study ID # NI 13016
Secondary ID ID RCB 2014-A009
Status Completed
Phase
First received
Last updated
Start date July 2014
Est. completion date December 31, 2017

Study information
Verified date August 2018
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 206
Est. completion date December 31, 2017
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group 3 Years to 3 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Premature infants with a GA < 32 weeks
At 3 years of age: ASQ (filled in by parents)

Locations
Country Name City State
France Hôpital Necker Assistance Publique- Hôpitaux de Paris Paris

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Neurological development Age and Stages Questionnaire At 3 years of age
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