Evaluation of an Infant Formula for Healthy Infants
Northern California Research is conducting a study to evaluate an infant formula for growth, safety, and efficacy in healthy term infants.
This study is open to both formula fed, as well as human milk fed infants, who will be included in the study as a reference group. Formula fed infants will be randomized into two groups – one with a standard, commercially available infant formula, and the other with the study formula.
Study duration is 16 weeks, plus an 8 week follow up period.
- Infants under 14 days old
- Healthy term and birth weight
- Designated as healthy as a physician
- Either exclusively formula or human milk fed and well tolerated
- Parents or guardians have read and signed informed consent
Infants who have medical conditions or take medications known to affect growth or development, have a family history of milk allergy, have been fed a mix of milk and formula, or infants from a multiple birth (twins, triplets, etc), may not qualify for this trial.
The trial doctor will review other eligibility criteria with you. All trial-related visits, tests, and medications will be provided to you at no cost. In addition, reimbursement for trial-related time and travel may be provided.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): To be determined