BabyNes Nutrition System Growth Study

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

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.

Study Overview

• Status: Completed
• Conditions: Growth
• Intervention / Treatment: Other: Formula fed with BabyNes Nutrition System

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Formula fed with BabyNes Nutrition System
No Intervention: Breastfeeding group; used as reference to compare with formula feeding group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the change in weight-for-age z-score of the WHO Child Growth Standard	from birth to 4 months of age

Secondary Outcome Measures

Outcome Measure	Time Frame
the Insulin, C-peptide, IGF-1 leptin and ghrelin level	at 4 and 12 months
length and head circumference measures	birth, 1, 2, 4, 6, 9 12 months of age
Body composition: fat mass, lean mass	4 months and 6 months

Collaborators and Investigators

• Sponsor: Nestlé

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: June 26, 2014
• First Submitted That Met QC Criteria: June 27, 2014
• First Posted (Estimate): June 30, 2014

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 11.20.INF