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

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ClinicalTrials.gov Identifier: NCT01094080
Recruitment Status : Active, not recruiting
First Posted : March 26, 2010
Last Update Posted : May 31, 2018
Sponsor:
Collaborator:
HiPP GmbH & Co. Vertrieb KG
Information provided by (Responsible Party):
Prof. Berthold Koletzko, Ludwig-Maximilians - University of Munich

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.


Condition or disease Intervention/treatment Phase
Infant Nutrition Other: standard infant formula Other: modified infant formula Other: breast milk Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 505 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Formula With Modified Content of Protein and Improved Fatty Acids and Their Impact on Infant Growth and Health
Study Start Date : February 2010
Actual Primary Completion Date : September 2011
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: standard infant formula
infants are fed a commercial formula during the first 4 month of life, according to protocol
Other: standard infant formula
infants are fed a commercial formula

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

breast milk
infants are breast fed
Other: breast milk
infants are breast fed




Primary Outcome Measures :
  1. change of weight from day 30 to day 120 [ Time Frame: postnatal age 30 to 120 days ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094080


Locations
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Germany
Hauner Childrens Hospital, LudwigMaximilans Universität
Muenchen, Germany, D-80337
Serbia
Institute for Gynecology and Obstretition of Clinical Center
Belgrade, Serbia, 11000
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
HiPP GmbH & Co. Vertrieb KG
Investigators
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Study Director: Berthold Koletzko, Prof. Hauner Children Hospital, Ludwig Maximilians Universität
Principal Investigator: Tatjana Nicolić Nicolić, Dr. Institute for Gynecology and Obstretition of Clinical Center Belgrade

Publications of Results:
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Responsible Party: Prof. Berthold Koletzko, Prof, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01094080     History of Changes
Other Study ID Numbers: 502042
First Posted: March 26, 2010    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018

Keywords provided by Prof. Berthold Koletzko, Ludwig-Maximilians - University of Munich:
fully formula fed
fully breast fed