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.
Study Type
OBSERVATIONAL
Enrollment
208
Banner Cardon Children's Medical Center
Mesa, Arizona, United States
Banner - University Medical Center Phoenix
Phoenix, Arizona, United States
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}
Time frame: 30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Average length of hospital stay
Time frame: 30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Average weight gain (g/day from birth to discharge)
Time frame: 30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Incidence of bronchopulmonary dysplasia (BPD)
Time frame: 30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Incidence of pulmonary effusion/hemorrhage
Time frame: 30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Incidence of NEC
Time frame: 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)
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Time frame: 30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Mortality rate
Time frame: 30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Incidence of PDA ligation
Time frame: 30 days