Prospective Evaluation in Older Premature, Untreated Breast Milk and Milk Processed by the Breast-milk Bank (ADiLL)
This study is currently recruiting participants.
Verified January 2013 by Centre Hospitalier Universitaire Dijon
Sponsor:
Centre Hospitalier Universitaire Dijon
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
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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 |
Resource links provided by NLM:
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
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 May 19, 2013