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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
  Purpose

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
Infant, Premature, Diseases
Fatty Acid Deficiency

Study Type: Observational
Study Design: 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

Further study details as provided by Centre Hospitalier Universitaire Dijon:

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 [ 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


Biospecimen Retention:   Samples Without DNA

blood sample milk


Estimated Enrollment: 90
Study Start Date: April 2012
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   up to 12 Hours
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626508

Contacts
Contact: denis semama +33 3 80 29 36 00 denis.semama@chu-dijon.fr

Locations
France
Centre Hospitalier Universitaire Recruiting
Dijon, Bourgogne, France, 21000
Contact: DENIS SEMAMA    +33 3 80 29 36 00    denis.semama@chu-dijon.fr   
Contact: MARC BARDOU    +33 3 80 39 34 33    marc.bardou@u-bourgogne.fr   
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
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01626508     History of Changes
Other Study ID Numbers: IACOBELLI PHRC IR 2011
Study First Received: June 18, 2012
Last Updated: January 4, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

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

Additional relevant MeSH terms:
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on November 23, 2014