Disturbance of Growth Clinical Trial
— HippHAOfficial 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
| Verified date | November 2017 |
| Source | HiPP GmbH & Co. Vertrieb KG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 503 |
| Est. completion date | August 2017 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A to 27 Days |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Universitätsklinik für Kinder- und Jugendheilkunde, Abt. Neonatologie, päd. Intensivmedizin und Neuropädiatrie | Wien | |
| Germany | Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie | Berlin | |
| Germany | Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum | Bochum | Nordrhein-Westfalen |
| Germany | University Hospital Rostock | Rostock | Mecklenburg-Vorpommern |
| Serbia | KBC "Dr Dragiša Mišovic Dedinje" | Belgrade |
| Lead Sponsor | Collaborator |
|---|---|
| HiPP GmbH & Co. Vertrieb KG | Charite University, Berlin, Germany |
Austria, Germany, Serbia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | average weight gain | The intervention is to assess average weight gain in the first 4 months of life. | 4 months | |
| Secondary | allergic sensitization and symptoms | blood sample to assess allergic predisposition | 12 months | |
| Secondary | Anthropometric data at age of 4 years | Weight, length and Head circumference measurements at Age of 4 years | 4 years | |
| Secondary | Body composition (Skin fold) at age of 4 years | Caliper measurement at Age of 4 years | 4 years | |
| Secondary | Body composition (fat mass, lean body mass) at age of 4 years | bioelectrical impedance Analysis at Age of 4 years | 4 years | |
| Secondary | Allergic predisposition at age of 4 years by measuring specific IgE in blood | blood sample to allergic predisposition at Age of 4 years | 4 years |