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

Primary Purpose

Patent Ductus Arteriosus

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cather closure of patent ductus arteriosus (PDA)
Conservative management of patent ductus arteriosus (PDA)
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patent Ductus Arteriosus focused on measuring catheter closure, conservative treatment, percutaneous closure

Eligibility Criteria

14 Days - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nationwide Children's Hospital
  • University of Tennessee Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Catheter-closure of PDA

Conservative management of PDA

Arm Description

Infants randomized to this group will undergo a catheter procedure to close hemodynamically-significant patent ductus arteriosus (HSPDA).

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.

Outcomes

Primary Outcome Measures

Change in ventilatory support required
Need for ventilator support, continuous positive airway pressure (CPAP) support, or nasal cannula support
Change in supplemental oxygen need
Amount of supplemental oxygen support required (in % fraction of inspired oxygen, FiO2)

Secondary Outcome Measures

Need for catheter-based closure (applies to Conservative management group only)
How often (incidence) infants assigned to conservative management require intervention; failure of treatment method

Full Information

First Posted
May 16, 2019
Last Updated
September 9, 2022
Sponsor
Nationwide Children's Hospital
Collaborators
University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT03982342
Brief Title
Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants
Acronym
PIVOTAL
Official Title
Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants (PIVOTAL)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID outbreak interrupted study recruitment
Study Start Date
December 4, 2019 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
Collaborators
University of Tennessee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Ductus Arteriosus
Keywords
catheter closure, conservative treatment, percutaneous closure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Enrolled participants will be randomly assigned to one of two PDA treatment approaches, both receiving treatment at the same time.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Catheter-closure of PDA
Arm Type
Active Comparator
Arm Description
Infants randomized to this group will undergo a catheter procedure to close hemodynamically-significant patent ductus arteriosus (HSPDA).
Arm Title
Conservative management of PDA
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cather closure of patent ductus arteriosus (PDA)
Other Intervention Name(s)
Percutaneous closure of patent ductus arteriosus (PDA)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conservative management of patent ductus arteriosus (PDA)
Intervention Description
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".
Primary Outcome Measure Information:
Title
Change in ventilatory support required
Description
Need for ventilator support, continuous positive airway pressure (CPAP) support, or nasal cannula support
Time Frame
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
Title
Change in supplemental oxygen need
Description
Amount of supplemental oxygen support required (in % fraction of inspired oxygen, FiO2)
Time Frame
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
Secondary Outcome Measure Information:
Title
Need for catheter-based closure (applies to Conservative management group only)
Description
How often (incidence) infants assigned to conservative management require intervention; failure of treatment method
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Days
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl H Backes, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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