An Observational Study to Characterize Human Milk From Mothers Delivering Term SGA and AGA Infants. (NCT02421445) | Clinical Trial Compass
CompletedNot Applicable
An Observational Study to Characterize Human Milk From Mothers Delivering Term SGA and AGA Infants.
India142 participantsStarted 2015-04
Plain-language summary
This is an observational study to characterize human milk of mothers delivering term SGA and term AGA infants. This is an observational, exploratory, longitudinal (from birth to 6 months postpartum), 4 parallel groups, and multi-centric study. Total 300 subjects will be randomised in the study assuming 20% dropout, 240 subjects will be enrolled. The recruitment period for the study in India is for 6 months.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. All mothers who delivered term infants, either SGA or AGA
✓. Mothers between 18 and 40 years of age inclusive, at the time of enrolment
✓. Having decided to predominantly breast-feed their new born baby at least until 6 months of age
✓. Having permanent residence at a maximum distance of 50km from the hospital/center of investigation for the duration of this study and being able to follow all the steps of this study
✓. Willing to provide informed consent according to the requirements of local regulations.
Exclusion criteria
✕. Preterm delivery (≤ 36 weeks + 6 days completed) of gestational age)
✕. Currently participating or having participated in an interventional clinical trial during the last 4 weeks prior to the beginning of this study
✕. Having a BMI ≥ 25.0
✕. Chewing tobacco, smoking or drinking alcohol (\> 1 glass per day), consuming illicit drugs during pregnancy or/and duration of the study
✕. Presenting any disease or medical condition which might prevent breast-feeding or collecting the human milk samples or for which breast-feeding is contraindicated
✕. Having diabetes or gestational diabetes mellitus
✕. Presenting dietary problems/illnesses such as anorexia, bulimia and celiac disease
What they're measuring
1
Maternal Milk Composition Characterization and Quantification
Timeframe: Visit 1 (Delivery - up to 72 hr post partum)
2
Maternal Milk Composition Characterization and Quantification
Timeframe: Visit 2 ( 6 week )
3
Maternal Milk Composition Characterization and Quantification
Timeframe: Visit 3 (10 Week)
4
Maternal Milk Composition Characterization and Quantification
Timeframe: Visit 4 (14 week)
5
Maternal Milk Composition Characterization and Quantification