Nutrition and Neurological Development of Very Preterm In... | NCT02184650

Studies
Nutrition and Neurological Development of Very Preterm Infants

NCT02184650

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Nov 20, 2025Actual

Enrollment

206Actual

Phase

Not provided

Conditions

Premature Infant
Infant Nutrition Disorders
Delayed Mental Development

Interventions

Premature infants with a GA < 32 weeks

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ID RCB 2014-A00941-46	Other Identifier	France: Ministry of Health

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014Actual

Primary Completion Date

Jul 2015Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

Jul 3, 2014

First Submission Date that Met QC Criteria

Jul 3, 2014

First Posted Date

Jul 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2025

Last Update Posted Date

Nov 20, 2025Actual

Name	Class
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

206Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Premature infants		Premature infants with a GA < 32 weeks	Other: Premature infants with a GA < 32 weeks

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Premature infants with a GA < 32 weeks	Other	At 3 years of age: ASQ (filled in by parents)	Premature infants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neurological development	Age and Stages Questionnaire	At 3 years of age

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

3 Years

Standard Ages

Child

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexandre Lapillonne, M.D, Ph.D.	Hôpital Necker Assistance Publique-Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Necker Assistance Publique- Hôpitaux de Paris		Paris		75015	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33910920	Result	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.

ID	Term
D047928	Premature Birth
D007228	Infant Nutrition Disorders

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications