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Low-protein Infant Formula With Partial or Extensive Proteinhydrolysate 4 Year Follow-up (HippHA)

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ClinicalTrials.gov Identifier: NCT01143233
Recruitment Status : Completed
First Posted : June 14, 2010
Last Update Posted : November 30, 2017
Sponsor:
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
HiPP GmbH & Co. Vertrieb KG

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The study is conducted to examine the suitability of partially respectively extensively hydrolyzed low protein infant formulae with and without pro- and prebiotics for healthy, term infants.

Primary hypothesis to be tested is: an infant formula based on a Protein hydrolysate with modified protein content is non inferior compared to a standard infant formula based on a Protein hyrolysate in respect to proper growth of healthy, term infants within the first four month of life.

4-year follow-up (without further Intervention) will focus on body composition and allergic predisposition.


Condition or disease Intervention/treatment Phase
Disturbance of Growth Other: control formula Other: intervention formula 1 Other: intervention formula 2 Other: intervention formula 3 Not Applicable

Detailed Description:
View Section Brief Summary

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 503 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Suitability of an Infant Formula With Reduced Protein Content Based on a Partial Respectively an Extensive Proteinhydrolysate With and Without Pro- and Prebiotics for the Particular Nutritional Use by Infants.-Extension by 4 Year Follow-up
Study Start Date : April 2010
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 2017

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: control formula group
infants are fed a commercial, hydrolysed formula during the first 4 month of life, according to protocol
 Other: control formula
infants are fed a commercial hydrolyzed formula
Experimental: intervention formula 1 group
infants are fed hydrolyzed infant formula with different protein content during the first 4 month of life, according to protocol
 Other: intervention formula 1
formula has hydrolysed protein and a different protein content
Experimental: intervention formula 2 group
infants are fed hydrolyzed infant formula with different protein content with pro- and prebiotics during the first 4 month of life, according to protocol
 Other: intervention formula 2
formula has hydrolysed protein, different protein content and pro- and prebiotics
Experimental: intervention formula 3 group
infants are fed hydrolyzed instant formula with different protein content with pro- and prebiotics during the first 4 months of life, according to protocol
 Other: intervention formula 3
formula has hydrolysed protein, different protein content and pro- and prebiotics
No Intervention: Reference group
infants are breast fed


Outcome Measures
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Primary Outcome Measures :
  1. average weight gain [ Time Frame: 4 months ]
    The intervention is to assess average weight gain in the first 4 months of life.


Secondary Outcome Measures :
  1. allergic sensitization and symptoms [ Time Frame: 12 months ]
    blood sample to assess allergic predisposition

  2. Anthropometric data at age of 4 years [ Time Frame: 4 years ]
    Weight, length and Head circumference measurements at Age of 4 years

  3. Body composition (Skin fold) at age of 4 years [ Time Frame: 4 years ]
    Caliper measurement at Age of 4 years

  4. Body composition (fat mass, lean body mass) at age of 4 years [ Time Frame: 4 years ]
    bioelectrical impedance Analysis at Age of 4 years

  5. Allergic predisposition at age of 4 years by measuring specific IgE in blood [ Time Frame: 4 years ]
    blood sample to allergic predisposition at Age of 4 years


Eligibility Criteria
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Ages Eligible for Study:   up to 27 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • written informed consent (by parents, caregiver)
  • Healthy term newborns (gestational age: ≥ 37 weeks)
  • Birth weight between 2.500 - 4.500 g
  • Age at enrolment: < 28 days of age
  • Infant received no other formula since birth
  • Parents / Caregivers are able to speak German

Exclusion Criteria:

  • Severe acquired or congenital illness
  • preterm infants (gestational age < 37 weeks)
  • Birth weight lower than 2.500 g or higher than 4.500 g
  • Feeding a cows milk based formula or any other formula prior to inclusion in this study
  • Participation in any other clinical study intervention
  • Regular intake of supplementary pre- and probiotics by the child and/or breastfeeding mother
  • Mothers with diabetes mellitus or mothers suffered from gestational diabetes
  • Founded assumption that it will not be possible for parents / caregivers to be compliant with the study protocol
  • Breastfed infants: illness of the mother, that may have an influence on the gastrointestinal tract of the child
  • Breastfed infants: mother receives or received antibiotics one week before inclusion in this study or during the first study phase
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01143233


Locations
Austria
Universitätsklinik für Kinder- und Jugendheilkunde, Abt. Neonatologie, päd. Intensivmedizin und Neuropädiatrie
Wien, Austria, 1090
Germany
University Hospital Rostock
Rostock, Mecklenburg-Vorpommern, Germany, 18059
Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum
Bochum, Nordrhein-Westfalen, Germany, 44791
Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
Berlin, Germany, 13353
Serbia
KBC "Dr Dragiša Mišović Dedinje"
Belgrade, Serbia, 11000
Sponsors and Collaborators
HiPP GmbH & Co. Vertrieb KG
Charite University, Berlin, Germany
Investigators
Principal Investigator: Ulrich Wahn, Prof. Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
Principal Investigator: Kirsten Beyer, Prof Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: HiPP GmbH & Co. Vertrieb KG
ClinicalTrials.gov Identifier: NCT01143233     History of Changes
Other Study ID Numbers: Hipp2010
First Posted: June 14, 2010    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017