Growth Clinical Trial - BabyNes Nutrition System Growth Study

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Growth

Clinical Trial Details

NCT number	NCT02178514
Study type	Interventional
Source	Nestlé
Contact
Status	Completed
Phase	N/A
Start date	December 2014
Completion date	May 2017

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.