Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PPRU 10824 | Other Identifier | Network Protocol Identifier |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pediatric Pharmacology Research Units Network | NETWORK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this protocol is to provide a mechanism for the ongoing collection of blood and urine samples in newborns that will be used to measure levels of antimicrobial products used in the newborn population where there are limited pharmacokinetic data in either premature or term infants.
Greater than 90% of infants born <32 weeks admitted to critical care nurseries are treated with antimicrobial agents during their NICU hospitalization. Most antimicrobial products used in the neonatal population lack some aspect of pharmacokinetic information specific to neonates. Dosing is based largely on pharmacokinetic data from older children or in some cases, adults. This study will also establish a bank of urine samples from newborns treated with antimicrobial and/or antifungal therapy and to characterize the urinary proteome in selected samples. The sites of the NIH-sponsored Pediatric Pharmacology Research Network (PPRU) have access to appropriate assays using microliter amounts of serum and a large pool of potential subjects to generate meaningful data that will
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| <26 weeks | Subjects <26 weeks gestational age |
| |
| 26-29 weeks | Subjects 26-29 weeks gestational age |
| |
| 30-32 weeks | Subjects 30-32 weeks gestational age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ampicillin | Drug | Drug prescribed per routine medical care. |
|
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Premature infants <32 weeks gestational age at birth at risk of infections.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Danny Benjamin, MD | PPRU | Principal Investigator |
| Mary Jayne Kennedy, Pharm, D | Louisville-PPRU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Diego | La Jolla | California | 92103 | United States | ||
| Children's National Medical Center |
Not provided
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D008795 | Metronidazole |
| D000077725 | Piperacillin, Tazobactam Drug Combination |
| D000212 | Acyclovir |
| D000666 | Amphotericin B |
| C068538 | liposomal amphotericin B |
| D000077612 | Anidulafungin |
| D000077336 | Caspofungin |
| ID | Term |
|---|---|
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Metronidazole | Drug | Drug prescribed per routine medical care. |
|
| Piperacillin/Tazobactam | Drug | Drug prescribed per routine medical care. |
|
| Acyclovir | Drug | Drug prescribed per routine medical care. |
|
| Amphotericin B | Drug | Drug prescribed per routine medical care. |
|
| Ambisome | Drug | Drug prescribed per routine medical care. |
|
| Anidulafungin | Drug | Drug prescribed per routine medical care. |
|
| Caspofungin | Drug | Drug prescribed per routine medical care. |
|
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Kosair Children's Hospital | Louisville | Kentucky | 40202 | United States |
| Children's Hospital of Michigan, Wayne State University | Detroit | Michigan | 48201 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75235 | United States |
| Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000078142 | Tazobactam |
| D010397 | Penicillanic Acid |
| D010878 | Piperacillin |
| D013450 | Sulfones |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D055666 | Lipopeptides |
| D008055 | Lipids |