NCT02184650

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

November 20, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

July 3, 2014

Last Update Submit

November 17, 2025

Conditions

Premature InfantInfant Nutrition DisordersDelayed Mental Development

Keywords

Premature infantsNutritional statusPolyunsaturated fatty acids status

Outcome Measures

Primary Outcomes (1)

  • Neurological development

    Age and Stages Questionnaire

    At 3 years of age

Study Arms (1)

Premature infants

Premature infants with a GA \< 32 weeks

Other: Premature infants with a GA < 32 weeks

Interventions

Premature infants with a GA < 32 weeksOTHER

At 3 years of age: ASQ (filled in by parents)

Premature infants

Eligibility Criteria

Age3 Years - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
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, and previously included in EPINUTRI study.

You may qualify if:

  • Premature infants previously included in EPINUTRI study
  • Non opposition of the parents for the collection of clinical and nutritional data

You may not qualify if:

  • Refusal of the parents to collect clinical and nutritional data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker Assistance Publique- Hôpitaux de Paris

Paris, 75015, France

Location

Related Publications (1)

  • Pierrat V, Marchand-Martin L, Marret S, Arnaud C, Benhammou V, Cambonie G, Debillon T, Dufourg MN, Gire C, Goffinet F, Kaminski M, Lapillonne A, Morgan AS, Roze JC, Twilhaar S, Charles MA, Ancel PY; EPIPAGE-2 writing group. Neurodevelopmental outcomes at age 5 among children born preterm: EPIPAGE-2 cohort study. BMJ. 2021 Apr 28;373:n741. doi: 10.1136/bmj.n741.

    PMID: 33910920RESULT

Biospecimen

Retention: NONE RETAINED

saliva, whole blood

MeSH Terms

Conditions

Premature BirthInfant Nutrition Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Alexandre Lapillonne, M.D, Ph.D.

    Hôpital Necker Assistance Publique-Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2014

First Posted

July 9, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2015

Study Completion

December 31, 2017

Last Updated

November 20, 2025

Record last verified: 2025-09

Locations

FR(1)