MedPath

Pre/Term Milk Profiling

Completed
Conditions
Preterm Milk
Term Milk
Registration Number
NCT02052245
Lead Sponsor
Société des Produits Nestlé (SPN)
Brief Summary

This study aims for an in-depth characterization of human milk of mothers who delivered prematurely to decipher differences with milk of mothers who delivered at the expected term, with a particular focus on milk proteins

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
61
Inclusion Criteria
  • Having obtained informed consent
  • Group 1 (term delivery): Gestational age between 37 0/7 and not above 41 6/7 weeks
  • Group 2 (preterm delivery): Gestational age between 28 0/7 and 32 6/7 weeks
  • Age: Mother ≥ 18 years old
  • Partial or total breast feeding
  • Having a freezer compartment at home (approx. -18°C)
  • Good understanding of the French language
Exclusion Criteria
  • Suffering from diabetes (type I or II) before pregnancy
  • Alcohol consumption: more than 1 standard drink / day
  • Drug addicted
  • Subject who cannot be expected to comply with the study procedures.
  • Currently participating in an interventional therapeutic clinical trial

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Quantification of total protein concentration in human milkfrom delivery, up to 4 months
Secondary Outcome Measures
NameTimeMethod
Determination of Calcium and Phosphorous contentFrom delivery, up to 4 months
Quantification of total lipids and carbohydratesFrom delivery, up to 4 months
Determination of peptide profiles and contentFrom delivery, up to 4 months
Determination of miRNA contentFrom delivery, up to 4 months

Trial Locations

Locations (1)

Clinic of neonatology - Avenue Pierre Decker 2

🇨🇭

Lausanne, Switzerland

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