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

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.

Study Overview

• Status: Completed
• Conditions: Infant, Premature, Diseases; Fatty Acid Deficiency

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• France
  • Bourgogne
    • Dijon, Bourgogne, France, 21000
      • Centre Hospitalier Universitaire
  • LA Reunion
    • Saint Pierre, LA Reunion, France, 97448
      • Centre Hospitalier Regional

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 12 hours (Child)
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon
• Collaborators: Centre Hospitalier Universitaire Saint Pierre

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: June 18, 2012
• First Submitted That Met QC Criteria: June 20, 2012
• First Posted (Estimated): June 22, 2012

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: breast milk; breast-milk bank; plasma profile; essential fatty acids
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infant, Premature, Diseases; Premature Birth
• Other Study ID Numbers: IACOBELLI PHRC IR 2011