PDA stands for patent ductus arteriosus, a heart issue where a blood vessel doesn't close as it should after birth. This study tests the Bloom Micro Occluder System to see if it safely helps fix this in babies born early. It takes place over 6 months and is not random, meaning all babies get the same treatment.
Eligibility:
- Babies must be at least 5 days old.
- The PDA must be a certain size (not bigger than 4.0 mm wide and at least 5 mm long).
- Babies need to weigh between 600 and 2500 grams.
Some babies won't qualify if they have other heart problems or infections.
- Key Points:
- Study lasts 6 months with regular check-ups.
- Babies will receive the same treatment.
- Eligibility depends on baby's age, size, and health status.