Nutrition and Neurological Development of Very Preterm Infants

Completed

• Conditions: Delayed Mental Development; Premature Infant; Infant Nutrition Disorders
• Interventions: Other: Premature infants with a GA < 32 weeks

• Registration Number: NCT02184650
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-03
• Study First Submitted QC: 2014-07-03
• Study First Posted: 2014-07-09
• Primary Completion: 2015-07
• Study Completion: 2017-12-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Premature infants	Premature infants with a GA < 32 weeks	Premature infants with a GA \< 32 weeks

Primary Outcome Measures

Name	Time	Method
Neurological development	At 3 years of age	Age and Stages Questionnaire

Trial Locations

Locations (1)

Hôpital Necker Assistance Publique- Hôpitaux de Paris; 🇫🇷 Paris, France