Clinical Trial: Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants

Brief Summary:

Patent Ductus Arteriosus 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 fail 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.

There are two ways to treat patent ductus arteriosus - one is through closure of the opening with an FDA approved device called PICCOLO, the other is through supportive management (medications).
No randomized controlled trials have been done previously to see if one of better than the other.
Through our PIVOTAL study, the investigators aim to determine is one is indeed better than the other - if it is found that the percutaneous closure with PICCOLO is better, then it would immediately lead to a new standard of care.
If not, then the investigators avoid an invasive costly procedure going forward.

Detailed Summary:
Sponsor: Nationwide Children's Hospital

Current Primary Outcome: Ventilator free days (VFDs) are defined as the number of days that a subject is alive and free from mechanical ventilatory support.
VFDs are an established respiratory outcome measure in pediatric clinical trials, and are a strong predictor of short-term and longer-term oucomes, including length of neonatal intensive care unit (NICU) stay, morbidities, and mortality.

Original Primary Outcome: Ventilator free days (VFDs) are defined as the number of days that a subject is alive and free from mechanical ventilatory support.
VFDs are an established respiratory outcome measure in pediatric clinical trials, and are a strong predictor of short-term and longer-term oucomes, including length of neonatal intensive care unit (NICU) stay, morbidities, and mortality.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Nationwide Children's Hospital

Dates:
Date Received: August 30, 2022
Date Started: February 21, 2023
Date Completion: February 21, 2023
Last Updated: November 12, 2023
Last Verified: November 01, 2023