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

NCT01626508 | Completed DMC

• 1 other identifier: IACOBELLI PHRC IR 2011
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Infant, Premature, Diseases; Fatty Acid Deficiency

Keywords

breast milk; breast-milk bank; plasma profile; essential fatty acids

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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 Criteria

• Age: 1 Minute - 12 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• Parent's written informed consent
• Gestational age less than 33 weeks of amenorrhea
• Intended enteral nutrition with breast milk

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead
• Centre Hospitalier Universitaire Saint Pierre: collaborator

Study Sites (2)

Centre Hospitalier Universitaire

Dijon, Bourgogne-Franche-Comté, 21000, France

Location

Centre Hospitalier Regional

Saint-Pierre, LA Reunion, 97448, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample milk

MeSH Terms

Conditions

Infant, Premature, Diseases

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: June 22, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

FR (2)