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

Patent Ductus Arteriosus Clinical Trial

— PIVOTAL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03982342
• Other study ID #: STUDY00000295
• Status: Terminated
• Phase: N/A
• Start date: October 10, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: February 2024
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Days to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

Device:
• Cather closure of patent ductus arteriosus (PDA)
Infants assigned to this group will have a catheter run from a blood vessel in the upper leg / groin area to the heart, where an FDA-approved device will be placed within the patent ductus arteriosus to occlude or plug it, thereby closing the ductus.

Other:
• Conservative management of patent ductus arteriosus (PDA)
Infants with a hemodynamically-significant patent ductus arteriosus randomized to this group will be treated by fluid restriction and possible diuretic use to reduce PDA symptoms, and allow time to permit the PDA to close or become reduced in size to the point where it is no longer considered "hemodynamically-significant".

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	University of Tennessee Health Science Center	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Nationwide Children's Hospital	University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time on Ventilatory Support Required	Period the participant is in need of ventilator support [Synchronized Intermittent Mandatory Ventilation (SIMV), High Frequency Oscillatory Ventilation (HFOV), or similar]	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
Primary	Supplemental Oxygen Need	Weekly supplemental oxygen support required (in % fraction of inspired oxygen, FiO2)	Post-randomization (up to 6 weeks) for participants in both groups.
Secondary	Number of Subjects Requiring Catheter-based Closure Due to Failed Conservative Management (Applies to Conservative Management Group Only)	How often (incidence) infants assigned to conservative management require intervention; failure of treatment method	6 weeks post-randomization (to conservative management group)