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

Not Applicable

Completed

• Conditions: Disturbance of Growth
• Interventions: Other: intervention formula 1; Other: intervention formula 2; Other: control formula; Other: intervention formula 3

• Registration Number: NCT01143233
• Lead Sponsor: HiPP GmbH & Co. Vertrieb KG

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.

Detailed Description

View Section Brief Summary

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-06-11
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Primary Completion: 2014-07
• Study Completion: 2017-08
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-29
• Last Update Posted: 2017-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 503

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention formula 1 group	intervention formula 1	infants are fed hydrolyzed infant formula with different protein content during the first 4 month of life, according to protocol
intervention formula 2 group	intervention formula 2	infants are fed hydrolyzed infant formula with different protein content with pro- and prebiotics during the first 4 month of life, according to protocol
control formula group	control formula	infants are fed a commercial, hydrolysed formula during the first 4 month of life, according to protocol
intervention formula 3 group	intervention formula 3	infants are fed hydrolyzed instant formula with different protein content with pro- and prebiotics during the first 4 months of life, according to protocol

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
allergic sensitization and symptoms	12 months	blood sample to assess allergic predisposition
Anthropometric data at age of 4 years	4 years	Weight, length and Head circumference measurements at Age of 4 years
Body composition (Skin fold) at age of 4 years	4 years	Caliper measurement at Age of 4 years
Body composition (fat mass, lean body mass) at age of 4 years	4 years	bioelectrical impedance Analysis at Age of 4 years
Allergic predisposition at age of 4 years by measuring specific IgE in blood	4 years	blood sample to allergic predisposition at Age of 4 years

Trial Locations

Locations (5)

KBC "Dr Dragiša Mišović Dedinje"; 🇷🇸 Belgrade, Serbia

Universitätsklinik für Kinder- und Jugendheilkunde, Abt. Neonatologie, päd. Intensivmedizin und Neuropädiatrie; 🇦🇹 Wien, Austria

University Hospital Rostock; 🇩🇪 Rostock, Mecklenburg-Vorpommern, Germany

Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum; 🇩🇪 Bochum, Nordrhein-Westfalen, Germany

Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie; 🇩🇪 Berlin, Germany