Prospective Evaluation in Older Premature, Untreated Breast Milk and Milk Processed by the Breast-milk Bank

NCT ID: NCT01626508

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-06-30

Brief Summary

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The purpose of this study is to evaluate the impact of the enteral nutrition type (untreated breast milk, or breast milk processed by the breast-milk bank) on the longitudinal evolution of the total content and plasma profile of essential fatty acids (EFA) in a population of premature infants.

Detailed Description

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Conditions

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Infant, Premature, Diseases Fatty Acid Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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breast-milk bank

breast milk collected and processed by the breast-milk bank before being used

No interventions assigned to this group

breast milk

breast milk used without any treatment, directly by children

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Parent's written informed consent
* Gestational age less than 33 weeks of amenorrhea
* Hospitalisation in an NICU at the time of inclusion
* Intended enteral nutrition with breast milk

Exclusion Criteria

* Persons not covered by the French social security system
* Major congenital malformation
* Participation in other biomedical study protocols
* Babies that are likely to be transferred to another hospital during the study period
Minimum Eligible Age

1 Minute

Maximum Eligible Age

12 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Universitaire

Dijon, Bourgogne-Franche-Comté, France

Site Status

Centre Hospitalier Regional

Saint-Pierre, LA Reunion, France

Site Status

Countries

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France

Other Identifiers

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IACOBELLI PHRC IR 2011

Identifier Type: -

Identifier Source: org_study_id

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