Growth Clinical Trial
Official title:
Do Infants Fed With BabyNes™ System Grow in Agreement With the World Health Organization (WHO) Reference?
Verified date | January 2018 |
Source | Nestlé |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | May 2017 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 4 Months |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
China | Children's Hospital of Fudan University | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Nestlé |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the change in weight-for-age z-score of the WHO Child Growth Standard | from birth to 4 months of age | ||
Secondary | the Insulin, C-peptide, IGF-1 leptin and ghrelin level | at 4 and 12 months | ||
Secondary | length and head circumference measures | birth, 1, 2, 4, 6, 9 12 months of age | ||
Secondary | Body composition: fat mass, lean mass | 4 months and 6 months |
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