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

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ClinicalTrials.gov Identifier: NCT02490852
Recruitment Status : Active, not recruiting
First Posted : July 7, 2015
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ausnutria Hyproca B.V.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Growth Other: Investigational infant formula Other: Active Comparator: Commercially available Infant formula Other: Active Comparator: Human milk Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Study of Nutritional Suitability of a New Infant Formula for Term Infants
Study Start Date : August 2015
Actual Primary Completion Date : August 22, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Weight gain [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 13 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490852


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
Sponsors and Collaborators
Ausnutria Hyproca B.V.
Investigators
Principal Investigator: Falco Panzer, Dr. Med. Kinderärztliche Gemeinschaftspraxis

Responsible Party: Ausnutria Hyproca B.V.
ClinicalTrials.gov Identifier: NCT02490852     History of Changes
Other Study ID Numbers: AUS/015513
First Posted: July 7, 2015    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: July 2017