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

Completed

Conditions studied: PDA, Low; Birthweight, Extremely (999 Grams or Less)

In brief

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.

Key facts

Study ID

NCT04379843

Run by

Pediatrix

People needed

208

Starts

2016-07-27

Expected to finish

2021-07-31

Last updated by the study team

2021-09-01

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All patients admitted to the BUMCP and CCMC NICUs with a birth weight ≤1000g and an echocardiogram-confirmed PDA, regardless of GA.

You may not qualify if…

• 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.

Where it is running

• Banner Cardon Children's Medical Center — Mesa, Arizona, United States
• Banner - University Medical Center Phoenix — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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