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| ID | Type | Description | Link |
|---|---|---|---|
| 591198726 | Other Identifier | MEDNAX CREQS |
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| Name | Class |
|---|---|
| Banner University Medical Center | OTHER |
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To evaluate whether utilizing a standardized patent ductus arteriosus (PDA) treatment algorithm in managing ELBW (extremely low birth weight) neonates ≤1000 grams (g) improves clinical outcomes and helps prevent undesirable side effects from PDAs.
The treatment of PDAs (patent ductus arteriosus) in both the premature and term neonatal population has been the source of thorough research for decades. Common treatment pathways include supportive care, pharmaceutical treatment (via indomethacin, ibuprofen, or acetaminophen), and surgical correction. Many PDAs self-resolve, some are not detected to adulthood, and others may never be discovered. However, determining which neonates with PDAs require pharmaceutical versus surgical management, and which can be managed with supportive care, can be difficult to differentiate. A standardized neonatal PDA treatment algorithm, one that assesses clinical significance, echocardiogram findings, and systemic PDA effects, and one that recommends the optimal treatment course based on these findings, would be helpful in medical management of neonatal PDAs in the ELBW (extremely low birth weight) population.
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| Measure | Description | Time Frame |
|---|---|---|
| To determine whether using a standardized PDA treatment algorithm improves clinical outcomes in the ELBW population (≤1000 g) with a documented PDA. | - Number of ventilation days {requirement of respiratory support of nasal continuous positive airway pressure (CPAP) or greater} | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs. | Average length of hospital stay | 30 days |
| To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs. |
| Measure | Description | Time Frame |
|---|---|---|
| For the group of subjects born after the implementation of the PDA algorithm, a determination will be made as to if the algorithm was followed appropriately. | Review of the subject's chart to determine if treatment algorithm was followed appropriately. | 30 days |
| For the group of subjects born after the implementation of the PDA algorithm, a determination will be made as to if the algorithm was followed appropriately. |
Inclusion Criteria:
Exclusion Criteria:
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Approximately 100-125 infants ≤1000g with a PDA are born or admitted each year between the BUMCP and CCMC NICUs. Including ELBW neonates over a space of four years will yield a sample size of up to 500, which should be large enough determine how effective the PDA algorithm has been.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Cardon Children's Medical Center | Mesa | Arizona | 85202 | United States | ||
| Banner - University Medical Center Phoenix |
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Average weight gain (g/day from birth to discharge) |
| 30 days |
| To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs. | Incidence of bronchopulmonary dysplasia (BPD) | 30 days |
| To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs. | Incidence of pulmonary effusion/hemorrhage | 30 days |
| To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs. | Incidence of NEC | 30 days |
| To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs. | Need for home oxygen (O2) (excluding for high altitude needs at home) | 30 days |
| To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs. | Mortality rate | 30 days |
| To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs. | Incidence of PDA ligation | 30 days |
Calculate compliance rate of algorithm among patients with PDAs. |
| 30 days |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| ID | Term |
|---|---|
| D001724 | Birth Weight |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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