Follow-up Study of Growth Safety and Efficacy of an Infant Formula for Healthy Term Infants

  • STATUS
    Recruiting
  • participants needed
    300
  • sponsor
    ByHeart
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Updated on 19 February 2024
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Summary

The purpose of this two-month follow-up study is to continue to follow growth, safety, and other health outcomes of infants fed a new infant formula for term infants or comparator formula. A reference group of human milk-fed infants will also be followed. This study is designed in accordance with Good Clinical Practice guidelines.

Details
Condition Healthy, Term Infants
Age 1years - 1years
Treatment Study Formula (SF), Comparator Formula (CF)
Clinical Study IdentifierNCT04389606
SponsorByHeart
Last Modified on19 February 2024

Eligibility

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Inclusion Criteria

Subjects who enrolled and completed the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

Exclusion Criteria

Subjects who did not enroll in the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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