NCT04379843

The Efficacy of Implementing a Treatment Algorithm in Managing Patent Ductus Arteriosus (PDA) in the Extremely Low Birth Weight Neonatal Population.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 208 (actual)
• Sponsor: Pediatrix · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• PDA
• Low; Birthweight, Extremely (999 Grams or Less)

Timeline

• Start date: 2016-07-27
• Primary completion: 2020-07-17
• Completion: 2021-07-31
• First posted: 2020-05-08
• Last updated: 2021-09-01

Locations

2 sites across 1 country: United States