NCT02178514

BabyNes Nutrition System Growth Study

Do Infants Fed With BabyNes™ System Grow in Agreement With the World Health Organization (WHO) Reference?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 4 Months
• Healthy volunteers: Accepted

Summary

Our main research question is: Do infants fed with BabyNes Nutrition System grow in agreement with the WHO reference? Our second question is: Do infants fed with BabyNes Nutrition System have a metabolic profile closer to breastfed infants? In order to answer both questions an observational trial will be carried out for 12 months in order to measure weight and to calculate the weight for age z-scores according to the WHO reference. A breastfeeding group will be used as reference for the metabolic parameters measured in blood of infants from Chinese background. The effect of the Babynes formulas will be compared to the metabolic values obtained from this breast-feeding reference group.

Detailed description

Design: 12 months-study, with a breastfeeding group for the comparison of metabolic values obtained from a Chinese Reference population. Number of subjects: In total, 120 subjects shall be enrolled. 80 subjects will be assigned in formula fed group and 40 subjects to breast feeding group. 20% dropouts are already considered for the sample size of 120. Product(s) to be tested: For formula fed group: * BabyNes 1 months: 0-1 month of age * BabyNes 2 months: 1-2 months of age * BabyNes 3-6 months: 3-6 months of age * BabyNes 7-12 months: 7-12 months of age For breast feeding group: * Nan HA 1 once the mothers are no more breastfed from 4 months until 6 months old. * Nan HA 2 once the mothers are no more breastfed from 6 months until 1 year old. Amount, dosage, route of administration, duration of study product: Subjects are included in the study for duration of upto 1 year old of the infant. For FF group: From birth to 4 months, they are exclusively fed with the infant formula dispenser (ad libitum). From 4 months of age they can start diversification but they maintain the adapted infant formula to the age until 12 months. For BF group: Mothers are encouraged to exclusively breast feed the infant up to 6 months old or at least until 4 months old. From 4 months of age, or later than 4 months with no more breastfeeding, they can start Nan HA1 / HA 2 (commercial formula) until the age of 12 months. The amount should be suitable for the age and appetite of the infants.

Conditions

• Growth

Interventions

Type	Name	Description
OTHER	Formula fed with BabyNes Nutrition System

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-11-01
• Completion: 2017-05-01
• First posted: 2014-06-30
• Last updated: 2018-01-30

Locations

1 site across 1 country: China