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CompletedNCT01585142Updated Jan 16, 2015

Growth of Infants Fed With BabyNes System

An interventional study of Test formula in Dietary Modification, sponsored by Société des Produits Nestlé (SPN). Completed at 4 sites in Switzerland. Open to participants aged Up to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-16.

Sponsored by Société des Produits Nestlé (SPN) · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
Up to 14 Days
Sex
All
01

Study summary

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.

02

Conditions studied

  • Dietary Modification
03

In context

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 14 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    BabyNes system formula

    Other: Test formula

Interventions

  • OtherTest formula

    Infant Formulas in powder in single-serve capsules (with a machine for dispensing, four consecutive formulas with customized composition

    Also known as: BabyNes System

06

What researchers measure

Primary outcomes

  1. z-score weight-for-age (WHO Child Growth Standards)

    Time frame: 4 months

Secondary outcomes

  1. Growth

    BMI for age z-scores, weight for length z-scores, length for age z-scores, head circumference for age z-scores

    Time frame: 12 months

  2. Compliance

    Volume of formula intake

    Time frame: 12 months

  3. Morbidity

    Number of infants with adverse events

    Time frame: 12 months

07

Study locations

4 sites
  • Universitäts-Kinderspital beider Basel (UKBB)
    Basel, 4031, Switzerland
  • Hôpital des enfants
    Geneva, 1205, Switzerland
  • CHUV Unité de Gastroentérologie Pédiatrique DMCP-BH11
    Lausanne, 1011, Switzerland
  • Pädiatrische Gastroenterologie und Hepatologie Kinderspital
    Luzern, 6000, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01585142
Lead sponsor
Société des Produits Nestlé (SPN)
Responsible party
Sponsor
First posted
Apr 25, 2012
Start date
Apr 2012
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Jan 16, 2015

Study contacts

Johannes Spalinger, Dr med.
principal investigator · Pädiatrische Gastroenterologie und Hepatologie Kinderspital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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