Infant Nutrition
Conditions
Keywords
fully formula fed, fully breast fed
Brief summary
In this study, the suitability of an infant formula with a modified content of protein and fatty acid pattern (LC-PUFA) for healthy term infants will be investigated. Primary hypothesis to be tested is: an infant formula with a modified protein content is non inferior compared to a standard infant formula in respect to the growth of healthy term infants.
Interventions
infants are fed a commercial formula
the modified infant formula has a different protein content than the standard formula and long chain polyunsaturated fatty acids are added
OTHERbreast milk
infants are breast fed
Sponsors
HiPP GmbH & Co. Vertrieb KG
Ludwig-Maximilians - University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Days to 28 Days
Healthy volunteers
Yes
Inclusion criteria
* healthy term newborn * gestational age between 37 and 41 weeks * birth weight between the 3th and 97th weight-for-age percentile according to the EURO-Growth charts * fully bottle-fed (at the latest with 28 days of age) or fully breast fed * written parental informed consent * Serbian nationality
Exclusion criteria
* malformations, congenital heart defect, congenital vascular disease, severe diseases of gastrointestinal tract, kidney, liver, central nervous system and/or metabolic disease * intensive care during first 14 days of life * participation in any other clinical study intervention * twins, multiple birth * neonatal infection * medication and parenteral nutrition * metabolic disorders * birth-related complications * severe disturbances of neonatal adaption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of weight from day 30 to day 120 | postnatal age 30 to 120 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood markers | postnatal day 30, day 60, day 90, day 120 days (120 only) | — |
| anthropometry | postnatal day 30, day 60, day 90, day 120 days | including body length, head circumference and derived parameter e.g. weight (from primary outcome) for length |
| Follow-up | 4 Years of age | At 4 Years of Age, an Interview Regarding Severe Events and Growth Since Study End Will be Performed and Anthropometric Data (Weight, Length, Head Circumference and Body Composition Measured Via Skinfolds and BIA) Will be Collected. |
| Follow-up at age 7 years with an interview regarding severe events and growth | 7 years of age | At 7 years of age we will perform anthropometric measurements (weight, height, head circumference and skinfolds) and bioimpedance measurement (from skinfolds and bioimpedance body composition will be estimated) additionally in an interview information on severe events (i.e. diseases) will be collected |
Countries
Germany, Serbia
Outcome results
None listed