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

Completed

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

• Registration Number: NCT04379843
• Lead Sponsor: Pediatrix

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.

Study Timeline

• Study Start: 2016-07-27
• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-08
• Primary Completion: 2020-07-17
• Study Completion: 2021-07-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether using a standardized PDA treatment algorithm improves clinical outcomes in the ELBW population (≤1000 g) with a documented PDA.	30 days	- Number of ventilation days {requirement of respiratory support of nasal continuous positive airway pressure (CPAP) or greater}

Secondary Outcome Measures

Name	Time	Method
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.	30 days	Incidence of PDA ligation

Trial Locations

Locations (2)

Banner - University Medical Center Phoenix; 🇺🇸 Phoenix, Arizona, United States

Banner Cardon Children's Medical Center; 🇺🇸 Mesa, Arizona, United States