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

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

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.

Study Overview

• Status: Completed
• Conditions: Disturbance of Growth
• Intervention / Treatment: Other: control formula; Other: intervention formula 1; Other: intervention formula 2; Other: intervention formula 3

Detailed Description

View Section Brief Summary

• Study Type: Interventional
• Enrollment (Actual): 503
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1090
    • Universitätsklinik für Kinder- und Jugendheilkunde, Abt. Neonatologie, päd. Intensivmedizin und Neuropädiatrie
• Germany
  • Berlin, Germany, 13353
    • Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
  • Mecklenburg-Vorpommern
    • Rostock, Mecklenburg-Vorpommern, Germany, 18059
      • University Hospital Rostock
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany, 44791
      • Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum
• Serbia
  • Belgrade, Serbia, 11000
    • KBC "Dr Dragiša Mišović Dedinje"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 3 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
average weight gain	The intervention is to assess average weight gain in the first 4 months of life.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
allergic sensitization and symptoms	blood sample to assess allergic predisposition	12 months
Anthropometric data at age of 4 years	Weight, length and Head circumference measurements at Age of 4 years	4 years
Body composition (Skin fold) at age of 4 years	Caliper measurement at Age of 4 years	4 years
Body composition (fat mass, lean body mass) at age of 4 years	bioelectrical impedance Analysis at Age of 4 years	4 years
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

Collaborators and Investigators

• Sponsor: HiPP GmbH & Co. Vertrieb KG
• Collaborators: 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

Publications and helpful links

General Publications

• Ahrens B, Hellmuth C, Haiden N, Olbertz D, Hamelmann E, Vusurovic M, Fleddermann M, Roehle R, Knoll A, Koletzko B, Wahn U, Beyer K. Hydrolyzed Formula With Reduced Protein Content Supports Adequate Growth: A Randomized Controlled Noninferiority Trial. J Pediatr Gastroenterol Nutr. 2018 May;66(5):822-830. doi: 10.1097/MPG.0000000000001853.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: June 11, 2010
• First Submitted That Met QC Criteria: June 11, 2010
• First Posted (Estimate): June 14, 2010

Study Record Updates

• Last Update Posted (Actual): November 30, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Hipp2010