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OpenTrials
Completed

NCT Number: NCT02490852

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

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.

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Key information

Conditions

Growth

Age range

Up to 13 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vienna, Austria

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Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Investigational infant formula

Other

fed ad libitum

Active Comparator: Commercially available Infant formula

Other

fed ad libitum

Active Comparator: Human milk

Other

fed ad libitum

Primary outcomes

  1. Weight gain

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Ausnutria Hyproca B.V.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 7, 2015
Registry last updated
May 21, 2019

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.

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