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

Infant, Premature, Diseases Clinical Trial

— ADiLL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626508
• Other study ID #: IACOBELLI PHRC IR 2011
• Status: Completed
• Start date: June 2012
• Est. completion date: June 2013

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 12 Hours

Eligibility

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

Related Conditions & MeSH terms

• Fatty Acid Deficiency
• Infant, Premature, Diseases
• Premature Birth

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Dijon	Bourgogne
France	Centre Hospitalier Regional	Saint Pierre	LA Reunion

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon	Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of the effects of the milk-treatment process at the milk bank on the composition of the milk in terms of FA	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	3 weeks after the establishment of enteral nutrition