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