Clinical trial NCT03982342: Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants
Official title: Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants (PIVOTAL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Patent Ductus Arteriosus
Keywords: catheter closure
conservative treatment
percutaneous closure
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Tennessee
First posted: 2019-06-11
Enrollment: 1
Sex: ALL
Minimum age (years): 14
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Enrolled participants will be randomly assigned to one of two PDA treatment approaches, both receiving treatment at the same time.
Primary purpose: TREATMENT

Brief summary: This is a pilot study to collect preliminary data for a larger, multicenter clinical trial proposal. The study will examine two strategies commonly used to treat preterm infants diagnosed with a patent ductus arteriosus (PDA). The PDA closes after birth for most term infants, but in many preterm infants, it remains open (patent). A PDA may present a complication for a number of short-term problems faced by preterm infants. Longer-term issues include the development of pulmonary hypertension and changes in the size and performance of the heart. There is ongoing debate as to whether or not the PDA requires intervention.

Detailed description: Preterm infants diagnosed with a hemodynamically-significant patent ductus arteriosus (HSPDA) will be included. Specific criteria will be followed to determine if a patent ductus arteriosus (PDA) is "hemodynamically significant". Infants will be randomized to two different approaches for management of the PDA. The first will be catheter-based closure (intervention) and the second will be conservative management (non-intervention). Both procedures are standard practice at many institutions, including Nationwide Children's Hospital. Infants randomized to receive intervention will undergo a procedure in which a catheter is used to place an FDA-approved device within the PDA, to close it (like a plug). Infants randomized to the conservative management (non-intervention) group will be permitted time to see if the PDA closes on its own, naturally. However, if the PDA remains open and intervention is deemed medically necessary, they will also undergo the catheter closure procedure.

Eligibility criteria: Maximum age (above) indicates qualifying / eligibility criteria. Participating infants will be followed until they reach 36 weeks corrected gestational age OR are discharged from the hospital, whichever comes first.

Inclusion Criteria:

* Preterm infants ≤28 weeks gestational age with hemodynamically-significant patent ductus arteriosus (PDA) at 2 - 4 weeks of age.
* Body weight greater than or equal to 700 grams

Exclusion Criteria:

* Significant genetic (ex.- Trisomy) or physiological (ex. - Omphalocele) abnormalities
* Other cardiac disease NOT INCLUDING atrial-septal defects or ventricular septal defects (ex. Tetrology of Fallot, Single ventricle physiology)
* Body weight less than 700 grams

Primary outcomes:
measure: Time on Ventilatory Support Required
timeFrame: Weekly for 1 month pre-closure (intervention group) or corresponding time point (non-intervention group); Weekly for 1 month post-closure (intervention group) or corresponding time point (non-intervention group); 36 weeks corrected gestational age
measure: Supplemental Oxygen Need
timeFrame: Post-randomization (up to 6 weeks) for participants in both groups.
Secondary outcomes:
measure: Number of Subjects Requiring Catheter-based Closure Due to Failed Conservative Management (Applies to Conservative Management Group Only)
timeFrame: 6 weeks post-randomization (to conservative management group)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
Study officials:
affiliation: Nationwide Children's Hospital
name: Carl H Backes, MD
role: PRINCIPAL_INVESTIGATOR
References: