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Completed

NCT Number: NCT01143233

Low-protein Infant Formula With Partial or Extensive Proteinhydrolysate 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.

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Key information

Conditions

Disturbance of Growth

Age range

1 day–27 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

View Section Brief Summary

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Formula

Other

infants are fed a commercial hydrolyzed formula

intervention formula 1

Other

formula has hydrolysed protein and a different protein content

intervention formula 2

Other

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

intervention formula 3

Other

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

Primary outcomes

  1. average weight gain

    Time frame: 4 months

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

Secondary outcomes

  1. allergic sensitization and symptoms

    Time frame: 12 months

    blood sample to assess allergic predisposition

  2. Anthropometric data at age of 4 years

    Time frame: 4 years

    Weight, length and Head circumference measurements at Age of 4 years

  3. Body composition (Skin fold) at age of 4 years

    Time frame: 4 years

    Caliper measurement at Age of 4 years

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

    Time frame: 4 years

    bioelectrical impedance Analysis at Age of 4 years

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

    Time frame: 4 years

    blood sample to allergic predisposition at Age of 4 years

Sponsors and collaborators

Lead sponsor

HiPP GmbH & Co. Vertrieb KG

Industry

Collaborators

  • Charite University, Berlin, Germany

Registry information

Official study 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

Acronym: HippHA

Important dates

Study start
2010
Primary completion
2014
Study completion
2017
First posted
Jun 14, 2010
Registry last updated
Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.