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To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator.
Hypothesize there will be no difference between formula groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Cow's milk based infant formula |
|
| 2 | Active Comparator | Partially hydrolyzed cow's milk based infant formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enfamil LIPIL with iron | Other | cow's milk based infant formula |
| |
| Good Start Supreme with DHA and ARA |
| Measure | Description | Time Frame |
|---|---|---|
| Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Infant temperament | 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol Berseth, MD | Mead Johnson Nutrition | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvey Pediatrics | Jonesboro | Arkansas | 22401 | United States | ||
| Mercy Rogers Pediatric Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19545360 | Derived | Berseth CL, Mitmesser SH, Ziegler EE, Marunycz JD, Vanderhoof J. Tolerance of a standard intact protein formula versus a partially hydrolyzed formula in healthy, term infants. Nutr J. 2009 Jun 19;8:27. doi: 10.1186/1475-2891-8-27. |
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| Other |
partially hydrolzed cow's milk protein |
|
| Rogers |
| Arkansas |
| 72756 |
| United States |
| Lovelace Scientific Resources | Santa Ana | California | 92704 | United States |
| Tampa Bay Medical Research | Clearwater | Florida | 33761 | United States |
| Children's Medical Association | Tamarac | Florida | 33321 | United States |
| Children's Health Care | DeKalb | Illinois | 60115 | United States |
| Welborn Clinic | Evansville | Indiana | 47714 | United States |
| Fomon Infant Nutrition Unit | Iowa City | Iowa | 52242 | United States |
| Heartland Research Associates | Wichita | Kansas | 67207 | United States |
| Pediatrics Clinical Trials Unit | Louisville | Kentucky | 40202 | United States |
| Pedia Research | Owensboro | Kentucky | 42301 | United States |
| Arklatex Children's Center | Bossier City | Louisiana | 71111 | United States |
| Craig Spiegel, MD | Bridgeton | Missouri | 63044 | United States |
| The Center for Human Nutrition | Omaha | Nebraska | 68105 | United States |
| Boystown | Omaha | Nebraska | 68124 | United States |
| Winthrop Pediatric Associates | Mineola | New York | 11501 | United States |
| Cary Pediatric Center | Cary | North Carolina | 27511 | United States |
| Collom and Carney Clinic | Texarkana | Texas | 75503 | United States |
| ID | Term |
|---|---|
| D007501 | Iron |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
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