Growth of Infants Fed With BabyNes System

Nestlé

Status: Completed

Conditions: Dietary Modification

Treatments: Other: Test formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01585142

11.18.INF

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: Under 14 days old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

33 participants in 1 patient group

BabyNes system formula

Experimental group

Treatment:

Other: Test formula