Study of Nutritional Suitability of a New Infant Formula for Term Infants

May 20, 2019 updated by: Ausnutria Hyproca B.V.
This is a growth study of full-term infants. The growth of infants fed the investigational formula will be compared with infants fed a control formula. A breastfeeding arm will be used as reference.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

304

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
  • Croatia
      • Dakovo, Croatia
      • Dubrovnik, Croatia
      • Kutina, Croatia
      • Split, Croatia
      • Vukovar, Croatia
      • Zadar, Croatia
      • Zagreb, Croatia
      • Zapresic, Croatia
  • Germany
      • Bramsche, Germany
      • Hamm, Germany
      • Herford, Germany
      • Mannheim, Germany
      • Monchengladbach, Germany
      • Wesel, Germany
      • Wuppertal, Germany
  • Spain
      • Barcelona, Spain
      • Madrid, Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy full term infant (37-42 weeks of gestational age)
  • Birth weight 2,500 to 4,500 g
  • Infant's mother willing and able to exclusively breast feed or infant's parent(s)/caregiver(s) willing to exclusively use randomized infant formula during study participation
  • Parent(s)/caregiver(s) able to attend visits and willing to complete the subject diary
  • Informed consent signed by parent(s)/caregiver(s)

Exclusion Criteria:

  • Congenital illness or malformation that may affect infant feeding or normal growth
  • Gastrointestinal disorders
  • Suspected or known allergy to milk protein for formula groups
  • Known food allergies in parents or siblings for formula groups
  • Multiples
  • Readmission to hospital for longer than 3 days for another reason than hyperbilirubinemia prior to enrollment
  • Infant participating in another clinical study
  • Infant's family unable to comply with the protocol according to the investigators's assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational Infant formula
Healthy term infants fed exclusively the investigational Infant Formula
Other: Investigational infant formula
fed ad libitum
Active Comparator: Commercially available Infant formula
Healthy term infants fed exclusively a commercially available Infant Formula
Other: Active Comparator: Commercially available Infant formula
fed ad libitum
Active Comparator: Human milk
Healthy term infants fed exclusively human milk
Other: Active Comparator: Human milk
fed ad libitum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight gain
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ausnutria Hyproca B.V.

Investigators

  • Principal Investigator: Falco Panzer, Dr. Med., Kinderärztliche Gemeinschaftspraxis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

August 22, 2018

Study Completion (Actual)

August 22, 2018

Study Registration Dates

First Submitted

June 29, 2015

First Submitted That Met QC Criteria

July 2, 2015

First Posted (Estimate)

July 7, 2015

Study Record Updates

Last Update Posted (Actual)

May 21, 2019

Last Update Submitted That Met QC Criteria

May 20, 2019

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • AUS/015513

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Growth

Clinical Trials on Investigational infant formula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe