BabyNes Nutrition System Growth Study
BabyNes Nutrition System Growth Study
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.
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.
Inclusion Criteria:

 Healthy newborns, whose mothers had a normal BMI before pregnancy and no diabetes Healthy
 newborn infant. Full term infant (≥ 37 weeks gestation and ≤ 42 weeks gestation). Birth
 weight ≥ 2500 g and ≤ 4500 g. Having obtained his/her signed legal representative's
 informed consent.

 For BF group:

 -  Exclusively breastfed since birth, the infant's mother agrees to exclusively breast
 feed her infant until at least to 4th month.

 -  Baby is 3 months (3 months ± 7 days) at enrollment.

 For FF group:

 -  Infant from birth to 21 days of age at the time of enrollment (the 21st day included).

 -  The infant's mother has voluntarily elected to exclusively formula feed her infant
 after enrolment.

 Exclusion Criteria:

 Congenital illness or malformation that may affect normal growth (especially
 immunodeficiency).

 Newborn whose mother's BMI was abnormal (<18.5 or >23.9) at start of pregnancy. Newborn
 whose mother has diabetes of type-1 or type-2 or other metabolic disorders.

 Newborn whose mother has a chronic infectious disease. Newborn whose parents / caregivers
 cannot be expected to comply with treatment. Newborn currently participating in another
 nutritional interventional clinical trial (except for vaccination studies).