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Completed

NCT Number: NCT04379843

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Banner Cardon Children's Medical Center, Mesa, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

    Time frame: 30 days

    • Number of ventilation days {requirement of respiratory support of nasal continuous positive airway pressure (CPAP) or greater}

Secondary outcomes

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

    Time frame: 30 days

    Average length of hospital stay

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

    Time frame: 30 days

    Average weight gain (g/day from birth to discharge)

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

    Time frame: 30 days

    Incidence of bronchopulmonary dysplasia (BPD)

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

    Time frame: 30 days

    Incidence of pulmonary effusion/hemorrhage

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

    Time frame: 30 days

    Incidence of NEC

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

    Time frame: 30 days

    Need for home oxygen (O2) (excluding for high altitude needs at home)

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

    Time frame: 30 days

    Mortality rate

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

    Time frame: 30 days

    Incidence of PDA ligation

Other outcomes

  1. 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.

    Time frame: 30 days

    Review of the subject's chart to determine if treatment algorithm was followed appropriately.

  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.

    Time frame: 30 days

    Calculate compliance rate of algorithm among patients with PDAs.

Sponsors and collaborators

Lead sponsor

Pediatrix

Other

Collaborators

  • Banner University Medical Center

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
May 8, 2020
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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