Growth of Infants Fed With BabyNes System

NCT ID: NCT01585142

Last Updated: 2015-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-07-31

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.

Conditions

Dietary Modification

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

BabyNes system formula

Group Type: EXPERIMENTAL

Test formula

Intervention Type: OTHER

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

Interventions

Test formula

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

Intervention Type: OTHER

Other Intervention Names

BabyNes System

Eligibility Criteria

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)

• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johannes Spalinger, Dr med.

Role: PRINCIPAL_INVESTIGATOR

Pädiatrische Gastroenterologie und Hepatologie Kinderspital

Locations

Universitäts-Kinderspital beider Basel (UKBB)

Basel, , Switzerland

Hôpital des enfants

Geneva, , Switzerland

CHUV Unité de Gastroentérologie Pédiatrique DMCP-BH11

Lausanne, , Switzerland

Pädiatrische Gastroenterologie und Hepatologie Kinderspital

Lucerne, , Switzerland

Countries

Switzerland

Other Identifiers

11.18.INF

Identifier Type: -

Identifier Source: org_study_id