Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low weight Infants (PIVOTAL)
Patent ductus arteriosus (PDA) affects more than 24,000 infants each year in the United States. It is the most diagnosed cardiovascular condition in preterm infants.
This condition is associated with increased mortality and many other harmful, longer-term outcomes, including chronic lung disease (CLD), intestinal injury, and brain damage. Treatment of this subgroup of infants with PDA via percutaneous catheter-closure may be an opportunity to improve their outcomes moving forward.
PDA is a developmental condition commonly observed among preterm infants.
It is a condition where the opening between the two major blood vessels leading from the heart fails to close after birth. In the womb, the opening (ductus arteriosus) is the normal part of the circulatory system of the baby, but is expected to close at full term birth. If the opening is tiny, the condition can be self-limiting. If not, medications/surgery are options for treatment. Nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen may initially be used in an attempt to close the patent ductus arteriosus (PDA).
If the PDA still remains open, there are two ways to treat patent ductus arteriosus – one is through closure of the opening with a medical device, and the other is through supportive and observational management (medications, fluid restriction, etc.).
It is a condition where the opening between the two major blood vessels leading from the heart fails to close after birth. In the womb, the opening (ductus arteriosus) is the normal part of the circulatory system of the baby, but is expected to close at full term birth. If the opening is tiny, the condition can be self-limiting. If not, medications/surgery are options for treatment. Nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen may initially be used in an attempt to close the patent ductus arteriosus (PDA).
If the PDA still remains open, there are two ways to treat patent ductus arteriosus – one is through closure of the opening with a medical device, and the other is through supportive and observational management (medications, fluid restriction, etc.).
No randomized controlled trials have compared these treatment options. PIVOTAL is designed to determine which treatment is best. If it is found that the percutaneous closure with the device leads to better outcomes, then it would immediately lead to a new standard of care. If not, then this type of procedure would be avoided by going forward using supportive and observational management.
No randomized controlled trials have compared these treatment options. PIVOTAL is designed to determine which treatment is best. If it is found that the percutaneous closure with the device leads to better outcomes, then it would immediately lead to a new standard of care. If not, then this type of procedure would be avoided by going forward using supportive and observational management.
