Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this clinical trial is to assess growth (rate of weight gain in grams per day) of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the first four months of life as compared to infants fed a standard infant formula.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard infant formula | Active Comparator |
| |
| Test formula | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard infant formula | Other | Standard infant formula given during the first 9 months of life, as per standard requirement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean weight gain | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| anthropometry, tolerance, morbidity, blood tests | 9 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan Feigelman, MD | University of Maryland School of Medicine, Department of Pediatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pedia Research, LLC | Newburgh | Indiana | 47630 | United States | ||
| Pedia Research, LLC |
Not provided
| ID | Term |
|---|---|
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Test formula | Other | Test formula enriched in lactoferrin given during the first 9 months of life, as per standard requirement. |
|
| Owensboro |
| Kentucky |
| 42301 |
| United States |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | United States |