NCT01486173

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

3.5 years

First QC Date

December 2, 2011

Last Update Submit

April 16, 2013

Conditions

Infant, Premature, DiseasesInfant Nutrition DisordersDevelopment; Delayed, Mental

Keywords

PUFAIronNeurological developmentPremature infant

Outcome Measures

Primary Outcomes (1)

  • Neurological development at 2 years of age

    Age and Stages Questionnaire at 2 years of age Brunet Lezine test

    3 years

Secondary Outcomes (1)

  • Nutritional status at time of discharge

    1 year

Study Arms (2)

Premature infants with a GA < 32 Weeks

New born with a GA > 37Weeks

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subsample of infants born very preterm (before 32 weeks of gestation) otherwise included in the French national cohort EPIPAGE 2

You may qualify if:

  • infants with a gestational age \< 32 weeks already included in the EPIPAGE2 study
  • agreement of parents

You may not qualify if:

  • death during hospitalisation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necker hospital

Paris, Île-de-France Region, 75014, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Infant, Premature, DiseasesInfant Nutrition DisordersPremature Birth

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutrition DisordersNutritional and Metabolic DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Alexandre Lapillonne, M.D., Ph.D.

    Alexandre Lapillonne

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

December 2, 2011

First Posted

December 6, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 17, 2013

Record last verified: 2013-04

Locations

FR(1)