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Completed

NCT Number: NCT01094080

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

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.

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Key information

Conditions

Infant Nutrition

Age range

3 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hauner Childrens Hospital, LudwigMaximilans Universität, München, Germany

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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 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

Treatment and study plan

Standard Infant Formula

Other

infants are fed a commercial formula

modified infant formula

Other

the modified infant formula has a different protein content than the standard formula and long chain polyunsaturated fatty acids are added

breast milk

Other

infants are breast fed

Primary outcomes

  1. change of weight from day 30 to day 120

    Time frame: postnatal age 30 to 120 days

Secondary outcomes

  1. anthropometry

    Time frame: 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

  2. blood markers

    Time frame: postnatal day 30, day 60, day 90, day 120 days (120 only)

  3. Follow-up

    Time frame: 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.

  4. Follow-up at age 7 years with an interview regarding severe events and growth

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • HiPP GmbH & Co. Vertrieb KG

Registry information

Acronym: BEMIM

Important dates

Study start
2010
Primary completion
2011
Study completion
2018
First posted
Mar 26, 2010
Registry last updated
Sep 2, 2020

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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