Growth of Infants Fed With BabyNes System

Dietary Modification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585142
• Other study ID #: 11.18.INF
• Status: Completed
• Phase: N/A
• First received: April 24, 2012
• Last updated: January 15, 2015
• Start date: April 2012
• Est. completion date: July 2014

Study information

• Verified date: January 2015
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 14 Days

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Dietary Modification

Intervention

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

Locations

Country	Name	City	State
Switzerland	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	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	z-score weight-for-age (WHO Child Growth Standards)		4 months	Yes
Secondary	Growth	BMI for age z-scores, weight for length z-scores, length for age z-scores, head circumference for age z-scores	12 months	Yes
Secondary	Compliance	Volume of formula intake	12 months	Yes
Secondary	Morbidity	Number of infants with adverse events	12 months	Yes