NCT02421445

An Observational Study to Characterize Human Milk From Mothers Delivering Term SGA and AGA Infants.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 142 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Small for Gestational Age (SGA) Infants
• Appropriate for Gestational Age (AGA) Infants

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-06-30
• Completion: 2018-12-30
• First posted: 2015-04-20
• Last updated: 2019-04-24

Locations

3 sites across 1 country: India