Early Nutrition and Neurological Development of Very Pret... | NCT01486173

Studies
Early Nutrition and Neurological Development of Very Preterm Infants

NCT01486173

Sponsor

Lapillonne, Alexandre, M.D.

Status

Unknown status

Last Update Posted

Apr 17, 2013Estimated

Enrollment

260Estimated

Phase

Not provided

Conditions

Infant, Premature, Diseases
Infant Nutrition Disorders
Development; Delayed, Mental

Interventions

Not provided

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

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Dec 2, 2011

First Submission Date that Met QC Criteria

Dec 5, 2011

First Posted Date

Dec 6, 2011Estimated

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

Apr 16, 2013

Last Update Posted Date

Apr 17, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alexandre Lapillonne, M.D., Ph.D., Professor of Pediatrics, Lapillonne, Alexandre, M.D.Principal Investigator

Lead Sponsor

Lapillonne, Alexandre, M.D.INDIV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

260Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neurological development at 2 years of age	Age and Stages Questionnaire at 2 years of age Brunet Lezine test	3 years

Secondary Outcomes

Measure	Description	Time Frame
Nutritional status at time of discharge	Polyunsaturated fatty acids status Iron status	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria:

death during hospitalisation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexandre Lapillonne, M.D., Ph.D.	Alexandre Lapillonne	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Necker hospital		Paris	Île-de-France Region	75014	France

Condition Browse Module

MeSH Terms

ID	Term
D007235	Infant, Premature, Diseases
D007228	Infant Nutrition Disorders
D047928	Premature Birth

Ancestor Terms

ID	Term
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Premature infants with a GA < 32 Weeks
New born with a GA > 37Weeks