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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01626508
Recruitment Status : Unknown
Verified January 2013 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : June 22, 2012
Last Update Posted : January 7, 2013
Centre Hospitalier Universitaire Saint Pierre
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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
Infant, Premature, Diseases Fatty Acid Deficiency

Study Type : Observational
Estimated 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 : April 2012

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

Primary Outcome Measures :
  1. Measurement of the effects of the milk-treatment process at the milk bank on the composition of the milk in terms of FA [ Time Frame: 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

Biospecimen Retention:   Samples Without DNA
blood sample milk

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Ages Eligible for Study:   up to 12 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
for both groups, the gestational age at birth must be less than 33 weeks gestation and at the time of inclusion the child must be hospitalized in neonatal resuscitation

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01626508

Contact: denis semama +33 3 80 29 36 00

Centre Hospitalier Universitaire Recruiting
Dijon, Bourgogne, France, 21000
Contact: DENIS SEMAMA    +33 3 80 29 36 00   
Contact: MARC BARDOU    +33 3 80 39 34 33   
Principal Investigator: denis semama         
Centre Hospitalier Regional Not yet recruiting
Saint Pierre, La Reunion, France, 97448
Contact: SILVIA IACOBELLI    +33 2 62 35 90 00      
Principal Investigator: SILVIA IACOBELLI         
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Centre Hospitalier Universitaire Saint Pierre

Responsible Party: Centre Hospitalier Universitaire Dijon Identifier: NCT01626508     History of Changes
Other Study ID Numbers: IACOBELLI PHRC IR 2011
First Posted: June 22, 2012    Key Record Dates
Last Update Posted: January 7, 2013
Last Verified: January 2013

Keywords provided by Centre Hospitalier Universitaire Dijon:
breast milk
breast-milk bank
plasma profile
essential fatty acids

Additional relevant MeSH terms:
Premature Birth
Infant, Premature, Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Newborn, Diseases