Clinical Trial: Nutrition and Neurological Development of Very Preterm Infants

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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 Summary:

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.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Neurological development [ Time Frame: At 3 years of age ]

Age and Stages Questionnaire


Original Primary Outcome: Neurological development [ Time Frame: At 5 years of age ]

Kaufman Assessment Battery for Children at 5 years of age


Current Secondary Outcome:

Original Secondary Outcome:

  • Neurological development at 3 years of age [ Time Frame: At 3 years of age ]
    Age and Stages Questionnaire
  • Cognitive and behavioral development at 5 years [ Time Frame: At 5 years of age ]
    Denver Developmental Screening test (DDST)
  • Physical growth at 5 years [ Time Frame: At 5 years of age ]
    Weight and height growth, head circumference, body mass index, abdominal circumference, waist circumference, mid upper arm circumference


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: July 3, 2014
Date Started: July 2014
Date Completion: December 2017
Last Updated: July 19, 2016
Last Verified: July 2016