Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure
NCT05321849
Cardiovascular Abnormalities, Cardiovascular Diseases
Jakarta, Indonesia
View Trial DetailsNCT Number: NCT04379843
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.
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Observational
Banner Cardon Children's Medical Center, Mesa, Arizona, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 30 days
Time frame: 30 days
Average length of hospital stay
Time frame: 30 days
Average weight gain (g/day from birth to discharge)
Time frame: 30 days
Incidence of bronchopulmonary dysplasia (BPD)
Time frame: 30 days
Incidence of pulmonary effusion/hemorrhage
Time frame: 30 days
Incidence of NEC
Time frame: 30 days
Need for home oxygen (O2) (excluding for high altitude needs at home)
Time frame: 30 days
Mortality rate
Time frame: 30 days
Incidence of PDA ligation
Time frame: 30 days
Review of the subject's chart to determine if treatment algorithm was followed appropriately.
Time frame: 30 days
Calculate compliance rate of algorithm among patients with PDAs.
Pediatrix
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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