PDANCT04379843
The Efficacy of Implementing a Treatment Algorithm in Managing Patent Ductus Arteriosus (PDA) in the Extremely Low Birth Weight Neonatal Population.
An observational study of PDA and Low; Birthweight, Extremely (999 Grams or Less), run by Pediatrix at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- PDA, Low; Birthweight, Extremely (999 Grams or Less)
- How many people
- 208 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jul 2016to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- All patients admitted to the BUMCP and CCMC NICUs with a birth weight ≤1000g and an echocardiogram-confirmed PDA, regardless of GA.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Banner Cardon Children's Medical Center
Mesa, Arizona, 85202
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85006
About this study
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.
Read the 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.
- Medical subject headings
- Birth Weight
What is being measured
The primary outcome is the main question the study is designed to answer.
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}
Measured: 30 days
Secondary outcomes (8)
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Average length of hospital stay
Measured: 30 days
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)
Measured: 30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Incidence of bronchopulmonary dysplasia (BPD)
Measured: 30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Incidence of pulmonary effusion/hemorrhage
Measured: 30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Incidence of NEC
Measured: 30 days
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)
Measured: 30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Mortality rate
Measured: 30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Incidence of PDA ligation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start27 Jul 2016
- Primary completion17 Jul 2020
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PDAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Collaborators
- Banner University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379843
- Sponsor's protocol ID
- 591107730
- Other IDs
- 591198726
- Status last verified
- Aug 2021
- First submitted
- 24 Apr 2020
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Implementing a Treatment Algorithm in Managing Patent Ductus Arteriosus (PDA) in the Extremely Low Birth Weight Neonatal Population.
- ClinicalTrials.gov ID
- NCT04379843
- Acronym / sponsor ID
- 591107730
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Collaborators
- Banner University Medical Center
- Study start
- 27 Jul 2016 (actual)
- Primary completion
- 17 Jul 2020 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients admitted to the BUMCP and CCMC NICUs with a birth weight ≤1000g and an echocardiogram-confirmed PDA, regardless of GA.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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}
8 secondary outcomes
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Time frame: 30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Time frame: 30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Time frame: 30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Time frame: 30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Time frame: 30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Time frame: 30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Time frame: 30 days
To determine whether using a standardized treatment algorithm helps prevent undesirable side effects from symptomatic PDAs.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for PDA
Active, not recruiting
PREEMIE: Study for Treatment of PDA in Premature Infants
Patent Ductus Arteriosus (PDA)
Active, not recruitingObservational study
Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
Patent Ductus Arteriosus
Active, not recruitingObservational study
PDA for Kidneys Study
Patent Ductus Arteriosus, Congenital Heart Disease
RecruitingPhase 2
Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
Patent Ductus Arteriosus After Premature Birth
Recruiting
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Congenital Heart Disease, Congenital Heart Disease (CHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PDA and Low; Birthweight, Extremely (999 Grams or Less), run by Pediatrix at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.