Growth of Infants Fed With BabyNes System

Assessment of Growth of Infants Fed With BabyNes System (Single-serve Formulas, Adaptative System)

The purpose of this study is to assess the growth of infants fed with BabyNes System, compared to the World Health Organization Reference, during the first four months of life.

Study Overview

• Status: Completed
• Conditions: Dietary Modification
• Intervention / Treatment: Other: Test formula

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Universitäts-Kinderspital beider Basel (UKBB)
  • Geneva, Switzerland, 1205
    • Hôpital des Enfants
  • Lausanne, Switzerland, 1011
    • CHUV Unité de Gastroentérologie Pédiatrique DMCP-BH11
  • Luzern, Switzerland, 6000
    • Pädiatrische Gastroenterologie und Hepatologie Kinderspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy newborn
• Full term newborn (≥ 37 weeks gestation)
• Birth weight ≥ 2500 g and ≤ 4500 g
• Newborn from birth to 14 days of age at the time of enrollment
• The newborn's mother has voluntarily elected to exclusively formula feed her newborn
• Having obtained his/her signed legal representative's informed consentHealthy newborn infant

Exclusion Criteria:

• Congenital illness or malformation that may affect normal growth (especially immunodeficiency)
• Newborn whose mother's BMI was abnormal (<18.5 or >30kg/m2) at start of pregnancy
• Newborn whose mother has diabetes of type-1 or type-2
• 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

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BabyNes system formula	Other: Test formula; Infant Formulas in powder in single-serve capsules (with a machine for dispensing, four consecutive formulas with customized composition; Other Names: BabyNes System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
z-score weight-for-age (WHO Child Growth Standards)	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth	BMI for age z-scores, weight for length z-scores, length for age z-scores, head circumference for age z-scores	12 months
Compliance	Volume of formula intake	12 months
Morbidity	Number of infants with adverse events	12 months

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Johannes Spalinger, Dr med., Pädiatrische Gastroenterologie und Hepatologie Kinderspital

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: April 24, 2012
• First Submitted That Met QC Criteria: April 24, 2012
• First Posted (Estimate): April 25, 2012

Study Record Updates

• Last Update Posted (Estimate): January 16, 2015
• Last Update Submitted That Met QC Criteria: January 15, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 11.18.INF