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Completed

NCT Number: NCT01585142

Growth of Infants Fed With BabyNes System

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.

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Key information

Conditions

Dietary Modification

Age range

Up to 14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitäts-Kinderspital beider Basel (UKBB), Basel, Switzerland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Test formula

Other

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

Other names: BabyNes System

Primary outcomes

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

    Time frame: 4 months

Secondary outcomes

  1. Growth

    Time frame: 12 months

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

  2. Compliance

    Time frame: 12 months

    Volume of formula intake

  3. Morbidity

    Time frame: 12 months

    Number of infants with adverse events

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 25, 2012
Registry last updated
Jan 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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