Trials Sponsors Conditions Drugs Pricing

Conditions

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

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
+3 more secondary outcomes

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

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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.

Sponsors & Collaborators

Banner University Medical Center
Othercollaborator
Pediatrix
Otherlead

Study Sites (2)

Banner Cardon Children's Medical Center

Mesa, Arizona, 85202, United States

Banner - University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

MeSH Terms

Conditions

Birth Weight

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Enrollment

208 participants (actual enrollment reported by the registry).

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

Actual (reported)

Primary Completion

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Other Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Other Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations