Clinical trial NCT02421445: An Observational Study to Characterize Human Milk From Mothers Delivering Term SGA and AGA Infants.
Official title: An Observational Study to Characterize Human Milk From Mothers Delivering Term SGA and AGA Infants.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small for Gestational Age (SGA) Infants
Appropriate for Gestational Age (AGA) Infants
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2015-04-20
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy (normal BMI) and undernourished (low BMI) women volunteers

Brief 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

Eligibility criteria: Inclusion Criteria:

1. All mothers who delivered term infants, either SGA or AGA
2. Mothers between 18 and 40 years of age inclusive, at the time of enrolment
3. Having decided to predominantly breast-feed their new born baby at least until 6 months of age
4. 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
5. Willing to provide informed consent according to the requirements of local regulations.

Exclusion Criteria:

1. Preterm delivery (≤ 36 weeks + 6 days completed) of gestational age)
2. Currently participating or having participated in an interventional clinical trial during the last 4 weeks prior to the beginning of this study
3. Having a BMI ≥ 25.0
4. Chewing tobacco, smoking or drinking alcohol (\> 1 glass per day), consuming illicit drugs during pregnancy or/and duration of the study
5. Presenting any disease or medical condition which might prevent breast-feeding or collecting the human milk samples or for which breast-feeding is contraindicated
6. Having diabetes or gestational diabetes mellitus
7. Presenting dietary problems/illnesses such as anorexia, bulimia and celiac disease
8. Subject unable to comply with study procedures or unable to come to hospital for the study visits.

Primary outcomes:
measure: Maternal Milk Composition Characterization and Quantification
timeFrame: Visit 1 (Delivery - up to 72 hr post partum)
measure: Maternal Milk Composition Characterization and Quantification
timeFrame: Visit 2 ( 6 week )
measure: Maternal Milk Composition Characterization and Quantification
timeFrame: Visit 3 (10 Week)
measure: Maternal Milk Composition Characterization and Quantification
timeFrame: Visit 4 (14 week)
measure: Maternal Milk Composition Characterization and Quantification
timeFrame: Visit 5 (24 week)
Secondary outcomes:
measure: Dietary intake
timeFrame: 3 consecutive days the week prior visit 2 (6 Week)
measure: Dietary intake
timeFrame: 3 consecutive days prior to visit 3 (10 Week)
measure: Dietary intake
timeFrame: 3 consecutive days prior to visit 4 (14 week)
measure: Dietary intake
timeFrame: 3 consecutive days prior to visit 5 (24 week)
measure: Maternal milk composition analysis
timeFrame: 5 visits from post delivery to 24 weeks.
measure: Associations of maternal and infant clinical parameters to maternal milk nutrients
timeFrame: 5 visits from post delivery to 24 weeks
Other outcomes:
Locations:
city: Delhi
country: India
facility: Muzumdar Shaw Medical Centre
state: Bangalore
city: Mysore
country: India
facility: Aadithya Adhikari Hospital
state: Karnataka
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
Study officials:
affiliation: Sir Ganga Ram Hospital, Delhi
name: Neelam Kler, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Muzumdar Shaw Medical Centre, Bengalore
name: Anil Kumar Sapare, DR
role: PRINCIPAL_INVESTIGATOR
affiliation: Aadithya Adhikari Hospital
name: Sarika Prasad, Dr
role: PRINCIPAL_INVESTIGATOR
References: