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

NCT01143233 | Completed DMC

• 1 other identifier: Hipp2010
• Study Type: interventional
• Target: 503
• Locations: 3 countries
• Sites: 5

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.

Conditions

Disturbance of Growth

Outcome Measures

Primary Outcomes (1)

• average weight gain

  The intervention is to assess average weight gain in the first 4 months of life.

  4 months

Secondary Outcomes (5)

• allergic sensitization and symptoms

  12 months

• Anthropometric data at age of 4 years

  4 years

• Body composition (Skin fold) at age of 4 years

  4 years

• Body composition (fat mass, lean body mass) at age of 4 years

  4 years

• Allergic predisposition at age of 4 years by measuring specific IgE in blood

  4 years

Study Arms (5)

control formula group

ACTIVE COMPARATOR

infants are fed a commercial, hydrolysed formula during the first 4 month of life, according to protocol

Other: control formula

intervention formula 1 group

EXPERIMENTAL

infants are fed hydrolyzed infant formula with different protein content during the first 4 month of life, according to protocol

Other: intervention formula 1

intervention formula 2 group

EXPERIMENTAL

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

intervention formula 3 group

EXPERIMENTAL

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

Reference group

NO INTERVENTION

infants are breast fed

Interventions

control formula OTHER

infants are fed a commercial hydrolyzed formula

control formula group

intervention formula 1 OTHER

formula has hydrolysed protein and a different protein content

intervention formula 1 group

intervention formula 2 OTHER

formula has hydrolysed protein, different protein content and pro- and prebiotics

intervention formula 2 group

intervention formula 3 OTHER

formula has hydrolysed protein, different protein content and pro- and prebiotics

intervention formula 3 group

Eligibility Criteria

• Age: 1 Day - 27 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Severe acquired or congenital illness
• preterm infants (gestational age \< 37 weeks)
• Birth weight lower than 2.500 g or higher than 4.500 g
• 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

Sponsors & Collaborators

• HiPP GmbH & Co. Vertrieb KG: lead
• Charite University, Berlin, Germany: collaborator

Study Sites (5)

Universitätsklinik für Kinder- und Jugendheilkunde, Abt. Neonatologie, päd. Intensivmedizin und Neuropädiatrie

Vienna, 1090, Austria

Location

University Hospital Rostock

Rostock, Mecklenburg-Vorpommern, 18059, Germany

Location

Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie

Berlin, 13353, Germany

Location

KBC "Dr Dragiša Mišović Dedinje"

Belgrade, 11000, Serbia

Location

Related Publications (1)

• 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.

  PMID: 29216020 DERIVED

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 14, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2017
• Last Updated: November 30, 2017

Record last verified: 2017-11

Locations

SE (1); DE (3); AU (1)