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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Centre Hospitalier Universitaire Dijon
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Saint Pierre
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01626508
First received: June 18, 2012
Last updated: January 4, 2013
Last verified: January 2013

June 18, 2012
January 4, 2013
April 2012
Not Provided
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 ] [ Designated as safety issue: No ]
  • 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
Not Provided
Complete list of historical versions of study NCT01626508 on ClinicalTrials.gov Archive Site
Not Provided
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 ] [ Designated as safety issue: No ]
  • 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
Not Provided
Not Provided
 
Prospective Evaluation in Older Premature, Untreated Breast Milk and Milk Processed by the Breast-milk Bank
Directed Donation of Untreated Milk or Milk Processed by the Breast-milk : Prospective Evaluation in Older Premature

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

blood sample milk

Probability Sample

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

  • Infant, Premature, Diseases
  • Fatty Acid Deficiency
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
Not Provided
Not Provided

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
Both
up to 12 Hours
No
Contact: denis semama +33 3 80 29 36 00 denis.semama@chu-dijon.fr
France
 
NCT01626508
IACOBELLI PHRC IR 2011
Yes
Centre Hospitalier Universitaire Dijon
Centre Hospitalier Universitaire Dijon
Centre Hospitalier Universitaire Saint Pierre
Not Provided
Centre Hospitalier Universitaire Dijon
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP