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

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Unknown status

CT.gov ID

NCT01626508

Collaborator

Centre Hospitalier Universitaire Saint Pierre (Other)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Infant, Premature, Diseases Fatty Acid Deficiency

Study Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Directed Donation of Untreated Milk or Milk Processed by the Breast-milk : Prospective Evaluation in Older Premature

Study Start Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
breast-milk bank breast milk collected and processed by the breast-milk bank before being used
breast milk breast milk used without any treatment, directly by children

Outcome Measures

Primary Outcome Measures

Measurement of the effects of the milk-treatment process at the milk bank on the composition of the milk in terms of FA [3 weeks after the establishment of enteral nutrition]
Level of total FA and composition of FA on samples of untreated breast milk immediately after the milk has been expressed Level of total FA and composition of FA on samples of breast milk provided by the milk bank just before being given to the infant

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 12 Hours

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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