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| ID | Type | Description | Link |
|---|---|---|---|
| 1R44HD057744-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the incidence of all nosocomial infections in prematurely-born infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Talactoferrin |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talactoferrin | Drug | Enteral, 150 mg/kg twice per day |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction in incidence of Late-Onset Infection defined by positive cultures and elevated C-reactive protein (CRP) | 1-3 months |
| Measure | Description | Time Frame |
|---|---|---|
| "NEC Scares", the "Neonatal Sepsis Syndrome" | 1-3 months | |
| Length of stay: The number of days of hospitalization from the date of birth until the day of discharge from the NICU | 1-3 months | |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rajesh Malik, MD | Contact | 713-552-1091 | rmalik@agennix.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital of Los Angeles | Recruiting | Los Angeles | California | 90027 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27260839 | Derived | Sherman MP, Adamkin DH, Niklas V, Radmacher P, Sherman J, Wertheimer F, Petrak K. Randomized Controlled Trial of Talactoferrin Oral Solution in Preterm Infants. J Pediatr. 2016 Aug;175:68-73.e3. doi: 10.1016/j.jpeds.2016.04.084. Epub 2016 May 31. | |
| 27234409 | Derived | Sherman MP, Sherman J, Arcinue R, Niklas V. Randomized Control Trial of Human Recombinant Lactoferrin: A Substudy Reveals Effects on the Fecal Microbiome of Very Low Birth Weight Infants. J Pediatr. 2016 Jun;173 Suppl:S37-42. doi: 10.1016/j.jpeds.2016.02.074. |
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| ID | Term |
|---|---|
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C515276 | talactoferrin alfa |
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| Placebo | Drug | Oral, twice per day |
|
| Mortality during hospitalization |
| 1-3 months |
| Kosair Children's Hospital |
| Recruiting |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| University of Louisville Hospital | Recruiting | Louisville | Kentucky | 40202 | United States |
| University of Missouri Health Care, Columbia Regional Hospital | Recruiting | Columbia | Missouri | 65201 | United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |