Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ByHeart
With
Paidion Research, Inc.
Age
0–0
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Term (no less than 37 weeks, 0 days and less than 42 weeks, 0 days), singleton infant.
Birth weight of greater than or equal to 2500 grams.
Designated healthy by a physician.
Less than or equal to 14 days of age at enrollment.
If formula fed, exclusively consuming and tolerating a cow's milk infant formula at enrollment and have a parent who agrees to feed the study formula as a sole source of nutrition for a minimum of 16 weeks.
If human milk fed, predominantly consuming and tolerating human milk and have a mother/parent who plans to predominantly feed human milk as sole source of nutrition for a minimum of 16 weeks.
Weight for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
Length for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
Head circumference for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
Weight for length greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
Not currently receiving and have a parent/guardian who does not plan to give pre- and/or pro-biotics for the full duration of the study.
Not currently participating in an interventional clinical trial and have a parent(s) or legal guardian(s) who agree not to enroll the infant in an interventional clinical trial while participating in this trial.
Have parent(s) or legal guardian(s) who are capable of completing the written records, questionnaires, and study procedures required by the protocol.
Have a parent(s) or legal guardian(s) who have read and voluntarily signed the Institutional Review Board Informed Consent prior to study participation.
You may not be if
Evidence of any anatomic or physiologic condition that would interfere with normal growth, development, or feeding.
Infants required to take medications know to influence growth and development.
Maternal history with known adverse effects on the fetus and/or the newborn infants.
Family history of cow milk protein allergy or soy intolerance/allergy.
Infants receiving any amount supplemental human milk with infant formula or visa-versa at time of enrollment.
Infants from a multiple birth.
Clareo Health | Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
