Growth of Infants Fed With BabyNes System
This study is currently recruiting participants.
Verified May 2013 by Nestlé
Sponsor:
Nestlé
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01585142
First received: April 24, 2012
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Dietary Modification |
Other: Test formula |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Assessment of Growth of Infants Fed With BabyNes System (Single-serve Formulas, Adaptative System) |
Further study details as provided by Nestlé:
Primary Outcome Measures:
- z-score weight-for-age (WHO Child Growth Standards) [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Growth [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]BMI for age z-scores, weight for length z-scores, length for age z-scores, head circumference for age z-scores
- Compliance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Volume of formula intake
- Morbidity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Number of infants with adverse events
| Estimated Enrollment: | 80 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: BabyNes system formula |
Other: Test formula
Infant Formulas in powder in single-serve capsules (with a machine for dispensing, four consecutive formulas with customized composition
Other Name: BabyNes System
|
Eligibility| Ages Eligible for Study: | up to 14 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01585142
Contacts
| Contact: Delphine Egli | +41219243238 | Delphine.Egli@nestle.com |
Locations
| Switzerland | |
| Universitäts-Kinderspital beider Basel (UKBB) | Recruiting |
| Basel, Switzerland, 4031 | |
| Contact: Raoul I. Furlano, Dr med | |
| Principal Investigator: Raoul I. Furlano, Dr med. | |
| Hôpital des enfants | Recruiting |
| Geneva, Switzerland, 1205 | |
| Contact: Dominique Belli, Prof Dr med | |
| Principal Investigator: Dominique Belli, Prof Dr med | |
| CHUV Unité de Gastroentérologie Pédiatrique DMCP-BH11 | Active, not recruiting |
| Lausanne, Switzerland, 1011 | |
| Pädiatrische Gastroenterologie und Hepatologie Kinderspital | Recruiting |
| Luzern, Switzerland, 6000 | |
| Contact: Johannes Spalinger, Dr med | |
| Principal Investigator: Johannes Spalinger, Dr med. | |
Sponsors and Collaborators
Nestlé
Investigators
| Principal Investigator: | Johannes Spalinger, Dr med. | Pädiatrische Gastroenterologie und Hepatologie Kinderspital |
More Information
No publications provided
| Responsible Party: | Nestlé |
| ClinicalTrials.gov Identifier: | NCT01585142 History of Changes |
| Other Study ID Numbers: | 11.18.INF |
| Study First Received: | April 24, 2012 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Switzerland: Ethikkommission |
Additional relevant MeSH terms:
|
Food Habits Habits |
ClinicalTrials.gov processed this record on May 22, 2013