Clinical trial NCT04379843: The Efficacy of Implementing a Treatment Algorithm in Managing Patent Ductus Arteriosus (PDA) in the Extremely Low Birth Weight Neonatal Population.
Official title: The Efficacy of Implementing a Treatment Algorithm in Managing Patent Ductus Arteriosus (PDA) in the Extremely Low Birth Weight Neonatal Population.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PDA
Low; Birthweight, Extremely (999 Grams or Less)
Lead sponsor: Pediatrix
Sponsor class: OTHER
Collaborators: name: Banner University Medical Center
First posted: 2020-05-08
Enrollment: 208
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 100-125 infants ≤1000g with a PDA are born or admitted each year between the BUMCP and CCMC NICUs. Including ELBW neonates over a space of four years will yield a sample size of up to 500, which should be large enough determine how effective the PDA algorithm has been.

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 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: To determine whether using a standardized PDA treatment algorithm improves clinical outcomes in the ELBW population (≤1000 g) with a documented PDA.
timeFrame: 30 days
Secondary outcomes:
measure: To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
timeFrame: 30 days
measure: To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
timeFrame: 30 days
measure: To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
timeFrame: 30 days
measure: To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
timeFrame: 30 days
measure: To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
timeFrame: 30 days
measure: To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
timeFrame: 30 days
measure: To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
timeFrame: 30 days
measure: To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
timeFrame: 30 days
Other outcomes:
measure: For the group of subjects born after the implementation of the PDA algorithm, a determination will be made as to if the algorithm was followed appropriately.
timeFrame: 30 days
measure: For the group of subjects born after the implementation of the PDA algorithm, a determination will be made as to if the algorithm was followed appropriately.
timeFrame: 30 days
Locations:
city: Mesa
country: United States
facility: Banner Cardon Children's Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Banner - University Medical Center Phoenix
state: Arizona
Study officials:
References: