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

NCT04379843 | Completed

• 2 other identifiers: 591107730591198726
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.

  30 days

• To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.

  30 days

• To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.

  30 days

• To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.

  30 days

• To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.

  30 days

Other Outcomes (2)

• 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.

  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.

  30 days

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Pediatrix: lead
• Banner University Medical Center: collaborator

Study Sites (2)

Banner Cardon Children's Medical Center

Mesa, Arizona, 85202, United States

Location

Banner - University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

MeSH Terms

Conditions

Birth Weight

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: May 8, 2020
• Study Start: July 27, 2016
• Primary Completion: July 17, 2020
• Study Completion: July 31, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)