Status:
COMPLETED
Low-protein Infant Formula With Partial or Extensive Proteinhydrolysate 4 Year Follow-up
Lead Sponsor:
HiPP GmbH & Co. Vertrieb KG
Collaborating Sponsors:
Charite University, Berlin, Germany
Conditions:
Disturbance of Growth
Eligibility:
All Genders
1-27 years
Phase:
NA
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 ...
Detailed Description
View Section Brief Summary
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
503 Patients enrolled
Trial Details
Trial ID
NCT01143233
Start Date
April 1 2010
End Date
August 1 2017
Last Update
November 30 2017
Active Locations (5)
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1
Universitätsklinik für Kinder- und Jugendheilkunde, Abt. Neonatologie, päd. Intensivmedizin und Neuropädiatrie
Vienna, Austria, 1090
2
University Hospital Rostock
Rostock, Mecklenburg-Vorpommern, Germany, 18059
3
Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum
Bochum, North Rhine-Westphalia, Germany, 44791
4
Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
Berlin, Germany, 13353