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.
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. The Primary Objective of the study is to characterize and quantify maternal milk composition from mothers of adequately nourished and under nourished status delivering term Small for Gestational Age (SGA) infants, compared to adequately-nourished and undernourished mothers delivering term Appropriate for Gestational Age (AGA) infants as defined in Fenton growth chart 2013. The secondary objective of the study is- 1. Association of maternal milk components with dietary intake and nourishment status of the mother. 2. Associations of maternal and infant clinical parameters to maternal milk nutrients. 3. To explore and analyze additional functional milk components, such as triacylglycerol, cholesterols, carotenoids, vitamins, microbiota, peptide profile, microRNA, cytokines, growth factors and hormones. The subject will enroll in the study after signing the Informed Consent Form after delivery the infants (i.e. term AGA \& term SGA) within 72 hours. Total Duration of the study for subject is 24 weeks. Sponsor will notify the end of study after 90 days of last subject last visit. Principal Investigator responsibility is to detect and document AE and SAE
Study Type
OBSERVATIONAL
Enrollment
142
Muzumdar Shaw Medical Centre
Delhi, Bangalore, India
Aadithya Adhikari Hospital
Mysore, Karnataka, India
Sir Ganga Ram Hospital
New Delhi, India
Maternal Milk Composition Characterization and Quantification
Milk samples collected for analyses of functional milk components, such as macronutrients (total fat, total protein, total lactose, total energy, crude proteins and total solids) and total protein analysis by BCA kit.
Time frame: Visit 1 (Delivery - up to 72 hr post partum)
Maternal Milk Composition Characterization and Quantification
Milk samples collected for analyses of functional milk components, such as macronutrients (total fat, total protein, total lactose, total energy, crude proteins and total solids) and total protein analysis by BCA kit.
Time frame: Visit 2 ( 6 week )
Maternal Milk Composition Characterization and Quantification
Milk samples collected for analyses of functional milk components, such as macronutrients (total fat, total protein, total lactose, total energy, crude proteins and total solids) and total protein analysis by BCA kit.
Time frame: Visit 3 (10 Week)
Maternal Milk Composition Characterization and Quantification
Milk samples collected for analyses of functional milk components, such as macronutrients (total fat, total protein, total lactose, total energy, crude proteins and total solids) and total protein analysis by BCA kit.
Time frame: Visit 4 (14 week)
Maternal Milk Composition Characterization and Quantification
Milk samples collected for analyses of functional milk components, such as macronutrients (total fat, total protein, total lactose, total energy, crude proteins and total solids) and total protein analysis by BCA kit.
Time frame: Visit 5 (24 week)
Dietary intake
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Assessed by a dietary questionnaire and correlated to infants and mothers'characteristics.
Time frame: 3 consecutive days the week prior visit 2 (6 Week)
Dietary intake
Assessed by a dietary questionnaire and correlated to infants and mothers'characteristics.
Time frame: 3 consecutive days prior to visit 3 (10 Week)
Dietary intake
Assessed by a dietary questionnaire and correlated to infants and mothers'characteristics.
Time frame: 3 consecutive days prior to visit 4 (14 week)
Dietary intake
Assessed by a dietary questionnaire and correlated to infants and mothers'characteristics.
Time frame: 3 consecutive days prior to visit 5 (24 week)
Maternal milk composition analysis
Other exploratory analyses such as fatty acids, cholesterol, phospholipids, gangliosides, oligosaccharides, peptides, amino acids, minerals, triacylglycerol, carotenoids, vitamins, microbiota, peptide profile, microRNA, cytokines, growth factors and hormones.
Time frame: 5 visits from post delivery to 24 weeks.
Associations of maternal and infant clinical parameters to maternal milk nutrients
Correlation of maternal milk composition to mother's diet, stage of lactation, type of delivery, sex of the infant, single/multiple birth, infant anthropometric measures (weight, length and head circumference), gestational age at birth and birth anthropometrics.
Time frame: 5 visits from post delivery to 24 weeks