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

Low; Birthweight, Extremely (999 Grams or Less) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379843
• Other study ID #: 591107730
• Secondary ID: 591198726
• Status: Completed
• Start date: July 27, 2016
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2021
• Source: Mednax Center for Research, Education, Quality and Safety
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: July 31, 2021
• Est. primary completion date: July 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• Ductus Arteriosus, Patent
• Low; Birthweight, Extremely (999 Grams or Less)
• PDA

Locations

Country	Name	City	State
United States	Banner Cardon Children's Medical Center	Mesa	Arizona
United States	Banner - University Medical Center Phoenix	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mednax Center for Research, Education, Quality and Safety	Banner University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.	Average length of hospital stay	30 days
Secondary	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
Secondary	To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.	Incidence of bronchopulmonary dysplasia (BPD)	30 days
Secondary	To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.	Incidence of pulmonary effusion/hemorrhage	30 days
Secondary	To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.	Incidence of NEC	30 days
Secondary	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
Secondary	To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.	Mortality rate	30 days
Secondary	To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.	Incidence of PDA ligation	30 days