Formula With Modified Content of Protein and Improved Fatty Acids and Their Impact on Infant Growth and Health

Study Overview
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Brief Summary
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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.

Official Title
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Formula With Modified Content of Protein and Improved Fatty Acids and Their Impact on Infant Growth and Health

Conditions
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Infant Nutrition

Intervention / Treatment
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* Other: standard infant formula
* Other: modified infant formula
* Other: breast milk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Days
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard infant formula<br>infants are fed a commercial formula during the first 4 month of life, according to protocol | Other: standard infant formula<br>* infants are fed a commercial formula<br>|
| Experimental: modified infant formula<br>infants are fed a modified infant formula (modified protein content and fatty acid pattern) during the first 4 month of life, according to protocol | Other: modified infant formula<br>* the modified infant formula has a different protein content than the standard formula and long chain polyunsaturated fatty acids are added<br>|
| Other: breast milk<br>infants are breast fed | Other: breast milk<br>* infants are breast fed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of weight from day 30 to day 120 |  | postnatal age 30 to 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anthropometry | including body length, head circumference and derived parameter e.g. weight (from primary outcome) for length | postnatal day 30, day 60, day 90, day 120 days | 
| blood markers |  | postnatal day 30, day 60, day 90, day 120 days (120 only) | 
| Follow-up | 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. | 4 Years of age | 
| Follow-up at age 7 years with an interview regarding severe events and growth | 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 | 7 years of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fully formula fed, fully breast fed