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| Name | Class |
|---|---|
| IQVIA RDS Inc. | INDUSTRY |
| ObvioHealth | INDUSTRY |
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The aim of this study is to assess age-appropriate growth of healthy infants fed a new infant formula. In this randomized, controlled trial, healthy, term, formula-fed infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants or the new infant formula for term infants for 16 weeks. A reference group of human milk-fed infants will also be enrolled. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. This study allows caregivers to participate completely from the comfort of their own home.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Infant Formula | Experimental | New infant formula for healthy term infants |
|
| Commercial Infant Formula | Active Comparator | Standard, commercially available infant formula for healthy term infants |
|
| Human Milk | No Intervention | Breastfed infants serve as a reference group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New Infant Formula | Other | New infant formula fed daily ad libitum |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Weight gain from baseline to 16 weeks feeding | Weight gain g/day | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Length gain from baseline to 16 weeks feeding | Length gain | 16 weeks |
| Head Circumference gain from baseline to 16 weeks feeding | Head Circumference gain |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of AEs | AEs reported during the study | 16 weeks |
| Caregiver report of tolerance obtained during 3-consecutive day intervals | Caregiver report of fussiness, gassiness, and spitting up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Parth Shah, MD FAPCR | ObvioHealth | Principal Investigator |
| Dawn Ross, Director Clinical Project Management | IQVIA RDS Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ObvioHealth | New York | New York | 10001 | United States |
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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A decentralized, randomized, controlled trial of healthy term breastfed and formula-fed infants for 16 weeks
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| Commercial Infant Formula |
| Other |
Commercially available infant formula fed daily ad libitum |
|
| 16 weeks |
| Volume of formula consumed during 3-consecutive day intervals | Volume of formula consumed | 16 weeks |
| 16 weeks |
| Caregiver report of stool characteristics obtained during 3-consecutive day intervals | Caregiver report of stool consistency, color, and frequency | 16 weeks |
| Stool collection for microbiome testing | Stool collection for microbiome testing at week 16 of feeding | 16 weeks |