Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT03614468
Eligibility Criteria:
Inclusion Criteria:
Infants will be eligible to participate if they meet all of the following conditions. At birth the infant must be:
Only infants whose parent(s) or legal guardian(s) have decided to feed infant formula as the sole source of nutrition, will be approached for potential study enrollment
1. Healthy, term (early term/no less than 37 weeks, 0 days through late term/no greater than 41 weeks, 6 days), singleton infant
2. Have a birth weight of ≥ 2500 grams
At the time of the baseline/enrollment visit, infants must be:
1. Designated as healthy by a physician
2. ≤21 days post-natal age (Date of Birth = Day 0)
3. Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
4. Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
5. Head circumference for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
6. Weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
7. Exclusively consuming and tolerating a cow's milk infant formula at time of enrollment
8. Have parent(s) or legal guardian(s) who agree to feed the study formula to the study subject as his/her sole source of nutrition for the duration of the study
9. Have parent(s) or legal guardian(s) who have read and voluntarily signed an Informed Consent form approved by the Institutional Review Board prior to any participation in the study.
Exclusion Criteria:
Infants will be ineligible if they have any of the following conditions that are judged by a physician to interfere with the infant's normal growth, development, and/or tolerance to an infant formula:
1. Infants showing evidence of anatomic and physiologic defects of the respiratory tract, or other congenital defects (as determined by the clinician)
2. Evidence of chronic hepatic, gastrointestinal, renal, cardiac, pulmonary, or neurological diseases
3. Having a maternal history with known adverse effects on the fetus and/or the newborn infant, such as diabetes (gestational diabetes is acceptable if infant's birth weight is \< 4300 g), active tuberculosis, perinatal infection,
4. Having a family history of cow's milk protein intolerance/allergy
5. Are an infant from a multiple birth (twin, triplet, etc.)
6. Mothers who smoked cigarettes
7. Mothers who used illicit drugs during pregnancy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
21 Days
Study:
NCT03614468
Study Brief:
Protocol Section:
NCT03614468