NCT01585142

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

2.2 years

First QC Date

April 24, 2012

Last Update Submit

January 15, 2015

Conditions

Dietary Modification

Outcome Measures

Primary Outcomes (1)

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

    4 months

Secondary Outcomes (3)

  • Growth

    12 months

  • Compliance

    12 months

  • Morbidity

    12 months

Study Arms (1)

BabyNes system formula

EXPERIMENTAL
Other: Test formula

Interventions

Test formulaOTHER

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

Also known as: BabyNes System
BabyNes system formula

Eligibility Criteria

AgeUp to 14 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

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 \>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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Universitäts-Kinderspital beider Basel (UKBB)

Basel, 4031, Switzerland

Location

Hôpital des enfants

Geneva, 1205, Switzerland

Location

CHUV Unité de Gastroentérologie Pédiatrique DMCP-BH11

Lausanne, 1011, Switzerland

Location

Pädiatrische Gastroenterologie und Hepatologie Kinderspital

Lucerne, 6000, Switzerland

Location

Study Officials

  • Johannes Spalinger, Dr med.

    Pädiatrische Gastroenterologie und Hepatologie Kinderspital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2012

First Posted

April 25, 2012

Study Start

April 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

January 16, 2015

Record last verified: 2015-01

Locations

CH(4)