Phase II Growth and Safety Study of an Infant Formula for Healthy Term Infants

Completed · Not applicable

Conditions studied: Infant Development

In brief

A goal of infant formula development is to mimic human milk (HM) both in nutrient composition as well as physiologic outcomes. investigators have developed an infant formula for term infants that more closely resembles the composition of human milk. The purpose of this study is to demonstrate that this formulation meets nutritional requirements and supports age appropriate growth of healthy term infants.

Key facts

Study ID

NCT04593147

Run by

Building Block Nutritionals, LLC

People needed

131

Starts

2020-10-14

Expected to finish

2021-11-09

Last updated by the study team

2021-11-15

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy, term (early term/no less than 37 weeks, 0 days through late term/no greater than 41 weeks, 6 days), singleton infant
• Have a birth weight of ≥ 2500 grams
• Designated as healthy by a physician
• ≤14 days post-natal age (Date of Birth = Day 0)
• Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
• Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
• Head circumference for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
• Weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
• Exclusively consuming and tolerating a cow's milk infant formula at time of enrollment
• 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
• 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
• 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.
• 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:

You may not qualify if…

• 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
• Show evidence of anatomic and physiologic defects of the respiratory tract, or other congenital defects (as determined by the clinician);
• Show evidence of chronic hepatic, gastrointestinal, renal, cardiac, pulmonary, or neurological diseases;
• Have 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, or substance abuse
• Have a family history of cow's milk protein intolerance/allergy
• Are an infant from a multiple birth (twin, triplet, etc.)

Where it is running

• PAS Research — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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