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Pre/Term Milk Profiling

Longitudinal Composition of Human Milk for Term and Preterm Infants

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02052245
Enrollment
61
Registered
2014-02-03
Start date
2013-10-31
Completion date
2014-07-31
Last updated
2014-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Milk, Term Milk

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

Interventions

None listed

Sponsors

Société des Produits Nestlé (SPN)
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Quantification of total protein concentration in human milkfrom delivery, up to 4 months

Secondary

MeasureTime frame
Quantification of total lipids and carbohydratesFrom delivery, up to 4 months
Determination of Calcium and Phosphorous contentFrom 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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026