Trials / Completed
CompletedNCT04389606
Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 311 (actual)
- Sponsor
- ByHeart · Industry
- Sex
- All
- Age
- 16 Weeks – 19 Weeks
- Healthy volunteers
- Accepted
Summary
The purpose of this two-month follow-up study is to continue to follow growth, safety, and other health outcomes of infants fed a new infant formula for term infants or comparator formula. A reference group of human milk-fed infants will also be followed. This study is designed in accordance with Good Clinical Practice guidelines.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Study Formula (SF) | New infant formula for term infants fed ad lib |
| OTHER | Comparator Formula (CF) | Commercially available infant formula for term infants fed ad lib |
Timeline
- Start date
- 2020-05-12
- Primary completion
- 2021-06-11
- Completion
- 2021-06-11
- First posted
- 2020-05-15
- Last updated
- 2021-07-21
Locations
27 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04389606. Inclusion in this directory is not an endorsement.