BabyNes Nutrition System Growth Study

NCT02178514 | Completed

• 1 other identifier: 11.20.INF
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Growth

Outcome Measures

Primary Outcomes (1)

• the change in weight-for-age z-score of the WHO Child Growth Standard

  from birth to 4 months of age

Secondary Outcomes (3)

• 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

Study Arms (2)

Formula Feeding group by BabyNes Nutrition System

EXPERIMENTAL

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

Breastfeeding group

NO INTERVENTION

used as reference to compare with formula feeding group

Interventions

Formula fed with BabyNes Nutrition System OTHER

Formula Feeding group by BabyNes Nutrition System

Eligibility Criteria

• Age: Up to 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: June 30, 2014
• Study Start: December 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: May 1, 2017
• Last Updated: January 30, 2018

Record last verified: 2018-01

Locations

CN (1)