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COVID outbreak interrupted study recruitment
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| Name | Class |
|---|---|
| University of Tennessee | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter-closure of PDA | Active Comparator | Infants randomized to this group will undergo a catheter procedure to close hemodynamically-significant patent ductus arteriosus (HSPDA). |
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| Conservative management of PDA | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cather closure of patent ductus arteriosus (PDA) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl H Backes, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States | ||
| University of Tennessee Health Science Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37659585 | Derived | Shah ZS, Clark RH, Patt HA, Backes CH Jr, Tolia VN. Trends in Procedural Closure of the Patent Ductus Arteriosus among Infants Born at 22 to 30 Weeks' Gestation. J Pediatr. 2023 Dec;263:113716. doi: 10.1016/j.jpeds.2023.113716. Epub 2023 Aug 31. |
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Single study participant was recruited, and informed consent documentation signed, in October of 2020 at Nationwide Children's Hospital in Columbus, Ohio.
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| ID | Title | Description |
|---|---|---|
| FG000 | Catheter-closure of PDA | Infants randomized to this group will undergo a catheter procedure to close hemodynamically-significant patent ductus arteriosus (HSPDA). 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 16, 2019 |
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Enrolled participants will be randomly assigned to one of two PDA treatment approaches, both receiving treatment at the same time.
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| Conservative management of patent ductus arteriosus (PDA) | Other | 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". |
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| Memphis |
| Tennessee |
| 38163 |
| United States |
| FG001 | Conservative Management of 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. 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. 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". |
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| NOT COMPLETED |
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Single participant was enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Catheter-closure of PDA | Infants randomized to this group will undergo a catheter procedure to close hemodynamically-significant patent ductus arteriosus (HSPDA). 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. |
| BG001 | Conservative Management of 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. 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. 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". |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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] | Single participant enrolled in preliminary trial, randomized to conservative management group. Period specified as outcome is the time (in weeks) post-randomization / group assignment that the subject continued to require ventilatory (SIMV) support. | Posted | Number | weeks | 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 |
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| Primary | Supplemental Oxygen Need | Weekly supplemental oxygen support required (in % fraction of inspired oxygen, FiO2) | Supplemental oxygen required while undergoing assigned treatment. If assignment was to the Conservative management group and rescue intervention was needed, this applies to the period prior to intervention. The calculation begins using the percentage oxygen on timepoint 0 (day 1, enrollment and randomization) using the weekly supplementary oxygen percentages (on day 7, day 14, day 21, etc up to day 56 post-randomization). | Posted | Number | percentage of oxygen | Post-randomization (up to 6 weeks) for participants in both groups. |
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| 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 | Single study participant enrolled continued to have a patent ductus arteriosus, ultimately qualifying for and receiving rescue intervention (catheter closure of the PDA). | Posted | Count of Participants | Participants | 6 weeks post-randomization (to conservative management group) |
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Adverse events (AEs): monitored weekly during hospitalization until discharge or up to 10 months. AEs specific to subjects undergoing catheter closure (noted below) will be monitored based upon the situation: 1) During the procedure (e.g., equipment failure, need for transfusion, intra-procedural embolization); 2) daily thereafter for one week (e.g., bruising at catheterization site, post-procedural embolization); 3) daily until resolution (e.g., blood clot formation requiring anticoagulation).
In addition to standard definitions, adverse events include issues related to cardiac catheterization, and specifically related to percutaneous closure of the patent ductus arteriosus. These include, but are not limited to: embolization of the implant; formation of a blood clot at the site of catheter access, requiring treatment; equipment and/or device failure during the catheterization procedure; allergic reaction to anesthesia for catheterization procedure, etc.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Catheter-closure of PDA | Infants randomized to this group will undergo a catheter procedure to close hemodynamically-significant patent ductus arteriosus (HSPDA). 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Conservative Management of 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. 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. 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". | 0 | 1 | 0 | 1 | 0 | 1 |
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The trial only enrolled a single patient prior to the COVID-19 epidemic. Due to subsequent COVID-19 restrictions placed upon clinical trials, the study was terminated early.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carl Backes, MD | Nationwide Children's Hospital | 1-614-355-6729 | Carl.Backes@nationwidechildrens.org |
| Dec 20, 2022 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004374 | Ductus Arteriosus, Patent |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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