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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
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Premature Infant Infant Nutrition Disorders Delayed Mental Development Other: Premature infants with a GA < 32 weeks

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.


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Study Type : Observational
Actual Enrollment : 206 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Premature infants
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)




Primary Outcome Measures :
  1. Neurological development [ Time Frame: At 3 years of age ]
    Age and Stages Questionnaire


Biospecimen Retention:   None Retained
saliva, whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subsample of infants born very preterm (before 32 weeks of gestation), otherwise included in the French national cohort EPIPAGE 2, and previously included in EPINUTRI study.
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
Hôpital Necker Assistance Publique- Hôpitaux de Paris
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Alexandre Lapillonne, M.D, Ph.D. Hôpital Necker Assistance Publique-Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02184650     History of Changes
Other Study ID Numbers: NI 13016
ID RCB 2014-A00941-46 ( Other Identifier: France: Ministry of Health )
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Premature infants
Nutritional status
Polyunsaturated fatty acids status

Additional relevant MeSH terms:
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Nutrition Disorders
Infant Nutrition Disorders