BabyNes Nutrition System Growth Study

NCT ID: NCT02178514

Last Updated: 2018-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-05-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Formula Feeding group by BabyNes Nutrition System

In this arm, all infants will be fed with BabyNes Nutrition System since enrollment until 12 month of age

Group Type: EXPERIMENTAL

Formula fed with BabyNes Nutrition System

Intervention Type: OTHER

Breastfeeding group

used as reference to compare with formula feeding group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Formula fed with BabyNes Nutrition System

Intervention Type: OTHER

Eligibility Criteria

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).

• Maximum Eligible Age: 4 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Children's Hospital of Fudan University

Shanghai, , China

Countries

China

Other Identifiers

11.20.INF

Identifier Type: -

Identifier Source: org_study_id