Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
Public ClinicalTrials.gov record NCT04218929. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to demonstrate that a new infant formula for term infants supports age-appropriate growth. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary efficacy objective is to compare the growth of infants randomized to the study infant formula (SF) versus growth of infants randomized to the standard commercial infant formula (CF).
Study identification
- NCT ID
- NCT04218929
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 311 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 0 Days to 14 Days
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 10, 2019 (Actual)
- Primary completion
- Jun 11, 2021 (Actual)
- Completion
- Jun 11, 2021 (Actual)
- Last update posted
- Jun 30, 2021
2019 – 2021
United States locations
- U.S. sites
- 27
- U.S. states
- 14
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics | Birmingham | Alabama | 35126 | — |
| Watching Over Mothers and Babies | Tucson | Arizona | 85712 | — |
| The Children's Clinic of Jonesboro, P.A. | Jonesboro | Arkansas | 72401 | — |
| Applied Research Center of Arkansas | Little Rock | Arkansas | 72212 | — |
| San Gabriel Women's Health | Arcadia | California | 91007 | — |
| Northern California Research | Sacramento | California | 95812 | — |
| Optum | Colorado Springs | Colorado | 80922 | — |
| Topaz Clinical Research | Apopka | Florida | 32703 | — |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| Avanza Medical Research | Pensacola | Florida | 32503 | — |
| PAS-Research | Tampa | Florida | 33613 | — |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | — |
| Southern Clinical Research | Zachary | Louisiana | 70791 | — |
| Sierra Clinical Research | Las Vegas | Nevada | 89106 | — |
| Pediatric Associates of Mt. Carmel, Inc | Cincinnati | Ohio | 45245 | — |
| Schear Family Practice | Dayton | Ohio | 45406 | — |
| Pediatric Associates of Fairfield, Inc. | Fairfield | Ohio | 45014 | — |
| Institute of Clinical Research | Mentor | Ohio | 44060 | — |
| Coastal Pediatric Research | Charleston | South Carolina | 29414 | — |
| Coastal Pediatric Associates | Summerville | South Carolina | 29486 | — |
| HMG Primary Care at Sapling Grove | Bristol | Tennessee | 37620 | — |
| Jackson Clinic North | Jackson | Tennessee | 38305 | — |
| HMG Pediatrics at Kingsport | Kingsport | Tennessee | 37660 | — |
| Houston Clinical Research Associates | Houston | Texas | 77090 | — |
| DCOL Center for Clinical Research | Longview | Texas | 75165 | — |
| ACRC Trials Plano Pediatrics | Plano | Texas | 75093 | — |
| Tanner Clinic | Layton | Utah | 84041 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04218929, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 30, 2021 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04218929 live on ClinicalTrials.gov.