Last updated on January 2020

Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Child Development
  • Age: - 1 Years
  • Gender: Male or Female

Inclusion Criteria:

  • 10-14 days of age at enrolment and randomization, inclusive (day of birth is considered day 0)
  • Plan to exclusively formula feed (formula groups) OR exclusively feed human milk (breastfeeding group)
  • Healthy singleton birth
  • Gestational age of 37-42 completed weeks (37 weeks 0 days through 42 weeks 6 days)
  • Birth weight of 2490g to 4200g
  • Signed informed consent obtained for infant's and mother's participation in the study

Exclusion Criteria:

  • History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant
  • Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion)
  • Known allergy to cow's milk protein or a well-documented family history of allergy to cow's milk protein
  • Weight at randomization is <90% of birth weight [(weight at Visit 1birth weight) x 100 <90%]
  • Immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others)
  • Known head/brain disease/injury such as microcephaly, macrocephaly or others.
  • Enrollment in another interventional clinical research study while participating in this study

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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