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

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Brief Title

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.

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 Type

Observational


Primary Outcome

To determine whether using a standardized PDA treatment algorithm improves clinical outcomes in the ELBW population (≤1000 g) with a documented PDA.

Secondary Outcome

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

Condition

PDA



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

500

Start Date

July 8, 2020

Completion Date

May 2022

Primary Completion Date

May 2022

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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04379843

Organization ID

591107730

Secondary IDs

591198726

Responsible Party

Sponsor

Study Sponsor

Mednax Center for Research, Education, Quality and Safety

Collaborators

 Banner University Medical Center

Study Sponsor

, , 


Verification Date

July 2020