Management of the Patent Ductus Arteriosus (PDA) Study

 

The ductus arteriosus is a small vessel in the heart that connects the main blood vessel that sends blood to the body. The ductus arteriosus is important when a baby is still inside its mother, but it is supposed to close after a baby is born. When it remains open (patent), it is called a Patent Ductus Arteriosus (PDA). PDAs are considered symptomatic if they cause problems with the lungs and heart.

There is a wide practice variation for the management of a symptomatic PDA because of the uncertainty of which approach is optimal. The Patent Ductus Arteriosus Study is a comparison of the two common ways to manage premature babies with a symptomatic PDA. These two ways are called “active care” and “expectant care” in this study. Active care is the use of medication, such as ibuprofen and acetaminophen, to help close the PDA. Expectant care, also known as the “watch and wait approach,” is where the baby will receive supportive care at the clinical team’s discretion. This study estimates the risks and benefits of active treatment versus expectant management of premature babies with PDAs.

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Purpose & Aim

Population of the study: Preterm infants 22 0/7 to 28 6/7 weeks gestation at birth.
Aim: Estimate the risks and benefits of active treatment versus expectant management of a symptomatic PDA in premature infants.
Outcome: The primary outcome for the study is death or bronchopulmonary dysplasia at 36 weeks post gestational age.

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Trial Information

Target Recruitment: 836 premature infants
Funder: NIH NICHD Neonatal Research Network (NRN)
Duration of Study: December 2018 – March 2029

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Study Principal Investigator

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Links

ClinicalTrials.gov