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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 208

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85202
      • Banner Cardon Children's Medical Center
    • Phoenix, Arizona, United States, 85006
      • Banner - University Medical Center Phoenix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.	Average length of hospital stay	30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.	Average weight gain (g/day from birth to discharge)	30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.	Incidence of bronchopulmonary dysplasia (BPD)	30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.	Incidence of pulmonary effusion/hemorrhage	30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.	Incidence of NEC	30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.	Need for home oxygen (O2) (excluding for high altitude needs at home)	30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.	Mortality rate	30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.	Incidence of PDA ligation	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Review of the subject's chart to determine if treatment algorithm was followed appropriately.	30 days
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.	Calculate compliance rate of algorithm among patients with PDAs.	30 days

Collaborators and Investigators

• Sponsor: Pediatrix
• Collaborators: Banner University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 27, 2016
• Primary Completion (ACTUAL): July 17, 2020
• Study Completion (ACTUAL): July 31, 2021

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (ACTUAL): May 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Body Weight; Heart Defects, Congenital; Cardiovascular Abnormalities; Birth Weight; Ductus Arteriosus, Patent
• Other Study ID Numbers: 591107730; 591198726 (OTHER: MEDNAX CREQS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No