Status:
COMPLETED
The Efficacy of Implementing a Treatment Algorithm in Managing Patent Ductus Arteriosus (PDA) in the Extremely Low Birth Weight Neonatal Population.
Lead Sponsor:
Pediatrix
Collaborating Sponsors:
Banner University Medical Center
Conditions:
PDA
Low; Birthweight, Extremely (999 Grams or Less)
Eligibility:
All Genders
Brief 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 he...
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 c...
Eligibility Criteria
Inclusion
- All patients admitted to the BUMCP and CCMC NICUs with a birth weight ≤1000g and an echocardiogram-confirmed PDA, regardless of GA.
Exclusion
- Patients who have serious comorbidities that are not directly related to their symptomatic PDA will be excluded (chromosomal abnormalities, serious kidney pathology, other hemodynamically significant heart defects, or serious comorbidities at the researcher's discretion). This will allow the researchers to better determine the efficacy of the treatment algorithm, without the results being confounded by unusual comorbidities.
Key Trial Info
Start Date :
July 27 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT04379843
Start Date
July 27 2016
End Date
July 31 2021
Last Update
September 1 2021
Active Locations (2)
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1
Banner Cardon Children's Medical Center
Mesa, Arizona, United States, 85202
2
Banner - University Medical Center Phoenix
Phoenix, Arizona, United States, 85006