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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01486173
Other study ID # 2011-mars-12551
Secondary ID
Status Active, not recruiting
Phase N/A
First received December 2, 2011
Last updated April 16, 2013
Start date June 2011
Est. completion date December 2014

Study information

Verified date April 2013
Source Lapillonne, Alexandre, M.D.
Contact n/a
Is FDA regulated No
Health authority France: The Commission nationale de l’informatique et des libertésFrance: Committee for the Protection of PersonnesFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Study type Observational

Clinical Trial Summary

The main goal of this study is to determine the association between:

- the quantity of mother's milk and duration of breastfeeding

- the intake of polyunsaturated fatty acids and iron during hospitalization and the development of preterm infants born with a GA < 32 weeks.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 260
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion criteria:

- infants with a gestational age < 32 weeks already included in the EPIPAGE2 study

- agreement of parents

Exclusion criteria:

- death during hospitalisation

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
France Necker hospital Paris Ile-de-France

Sponsors (1)

Lead Sponsor Collaborator
Lapillonne, Alexandre, M.D.

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neurological development at 2 years of age Age and Stages Questionnaire at 2 years of age
Brunet Lezine test
3 years No
Secondary Nutritional status at time of discharge Polyunsaturated fatty acids status
Iron status
1 year No
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