PREEMIE: Study for Treatment of PDA in Premature Infants

Launched by MERIT MEDICAL SYSTEMS, INC. · Sep 5, 2024

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ClinConnect Summary

The PREEMIE study is looking at a new treatment option for premature infants with a condition called patent ductus arteriosus (PDA). PDA is when a blood vessel in the heart doesn’t close properly after birth, which can cause problems for the baby. This trial is testing a device called The Bloom Micro Occluder System to see if it is safe and effective for closing this vessel in infants. The study will follow the babies for 6 months to gather important information about their health and recovery.

To be eligible for this study, infants must be at least 5 days old and weigh between 600 and 2500 grams. They need to have a significant PDA that is less than or equal to 4.0 mm wide and at least 5 mm long. However, infants with certain heart conditions or infections will not be able to participate. If a baby joins the study, parents can expect close monitoring and care as the researchers assess how well the device works. This study is currently recruiting participants, and it's a chance to help advance treatments for these vulnerable little ones.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject is age ≥5 days at time of enrollment.
• • Subject has a diagnosis of a hemodynamically significant patent ductus arteriosus (PDA) requiring closure.
• • Subject has a PDA is ≤4.0 mm in diameter.
• • Subject has a PDA is ≥5 mm in length.
• • Subject's weight is between 600-2500 grams at time of enrollment.
• Exclusion Criteria:
• • Subject has pre-existing coarctation of the aorta.
• • Subject has pre-existing left pulmonary artery stenosis.
• • Subject has an Intracardiac thrombus that may interfere with the implant procedure
• • Subject has other known hemodynamically significant congenital heart disease conditions at time of enrollment requiring intervention, e.g., valvular atresia, Tetralogy of Fallot, atrial septal defect, ventricular septal defect, transposition of the great vessels, etc.
• • Subject has an active systemic infection at the time of enrollment.