Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants

Not Applicable

Terminated

Interventions: Device: Cather closure of patent ductus arteriosus (PDA)
Other: Conservative management of patent ductus arteriosus (PDA)

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Catheter-closure of PDA	Cather closure of patent ductus arteriosus (PDA)	Infants randomized to this group will undergo a catheter procedure to close hemodynamically-significant patent ductus arteriosus (HSPDA).
Conservative management of PDA	Cather closure of patent ductus arteriosus (PDA)	Infants randomized to this group will be treated to reduce the symptoms of a hemodynamically-significant patent ductus arteriosus (HSPDA), in the hopes that over time the HSPDA will become reduced in size (to the point of no longer meeting criteria for being "hemodynamically significant") or close naturally. Infants in this group with declining health status attributable to a PDA which meet qualifying criteria may receive catheter closure (intervention) if deemed medically necessary.
Conservative management of PDA	Conservative management of patent ductus arteriosus (PDA)	Infants randomized to this group will be treated to reduce the symptoms of a hemodynamically-significant patent ductus arteriosus (HSPDA), in the hopes that over time the HSPDA will become reduced in size (to the point of no longer meeting criteria for being "hemodynamically significant") or close naturally. Infants in this group with declining health status attributable to a PDA which meet qualifying criteria may receive catheter closure (intervention) if deemed medically necessary.

Primary Outcome Measures

Name	Time	Method
Time on Ventilatory Support Required	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	Period the participant is in need of ventilator support \[Synchronized Intermittent Mandatory Ventilation (SIMV), High Frequency Oscillatory Ventilation (HFOV), or similar\]
Supplemental Oxygen Need	Post-randomization (up to 6 weeks) for participants in both groups.	Weekly supplemental oxygen support required (in % fraction of inspired oxygen, FiO2)

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Requiring Catheter-based Closure Due to Failed Conservative Management (Applies to Conservative Management Group Only)	6 weeks post-randomization (to conservative management group)	How often (incidence) infants assigned to conservative management require intervention; failure of treatment method

Locations (2): University of Tennessee Health Science Center
🇺🇸
Memphis, Tennessee, United States
Nationwide Children's Hospital
🇺🇸
Columbus, Ohio, United States