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

August 31, 2021 updated by: Pediatrix
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
208

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 30 days
- Number of ventilation days {requirement of respiratory support of nasal continuous positive airway pressure (CPAP) or greater}
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Time Frame: 30 days
Average length of hospital stay
30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Time Frame: 30 days
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.
Time Frame: 30 days
Incidence of bronchopulmonary dysplasia (BPD)
30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Time Frame: 30 days
Incidence of pulmonary effusion/hemorrhage
30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Time Frame: 30 days
Incidence of NEC
30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Time Frame: 30 days
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.
Time Frame: 30 days
Mortality rate
30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Time Frame: 30 days
Incidence of PDA ligation
30 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.
Time Frame: 30 days
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.
Time Frame: 30 days
Calculate compliance rate of algorithm among patients with PDAs.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pediatrix

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Banner University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 17, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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