Preterm Milk Clinical Trial
Official title:
Longitudinal Composition of Human Milk for Term and Preterm Infants
| Verified date | September 2014 |
| Source | Nestlé |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Ethikkommission |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 61 |
| Est. completion date | July 2014 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Clinic of neonatology - Avenue Pierre Decker 2 | Lausanne |
| Lead Sponsor | Collaborator |
|---|---|
| Nestlé |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Quantification of total protein concentration in human milk | from delivery, up to 4 months | No | |
| Secondary | Quantification of total lipids and carbohydrates | From delivery, up to 4 months | No | |
| Secondary | Determination of Calcium and Phosphorous content | From delivery, up to 4 months | No | |
| Secondary | Determination of peptide profiles and content | From delivery, up to 4 months | No | |
| Secondary | Determination of miRNA content | From delivery, up to 4 months | No |