Skip to main content
OpenTrials
Completed

NCT Number: NCT02052245

Pre/Term Milk Profiling

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Preterm Milk Term Milk

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Clinic of neonatology - Avenue Pierre Decker 2

Lausanne, 1011, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Quantification of total protein concentration in human milk

    Time frame: from delivery, up to 4 months

Secondary outcomes

  1. Quantification of total lipids and carbohydrates

    Time frame: From delivery, up to 4 months

  2. Determination of Calcium and Phosphorous content

    Time frame: From delivery, up to 4 months

  3. Determination of peptide profiles and content

    Time frame: From delivery, up to 4 months

  4. Determination of miRNA content

    Time frame: From delivery, up to 4 months

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Longitudinal Composition of Human Milk for Term and Preterm Infants

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 3, 2014
Registry last updated
Sep 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.