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出境医 / 临床实验 / Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants (PIVOTAL)
Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants (PIVOTAL)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Patent Ductus Arteriosus | Device: Cather closure of patent ductus arteriosus (PDA) Other: Conservative management of patent ductus arteriosus (PDA) | Not Applicable |
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.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Enrolled participants will be randomly assigned to one of two PDA treatment approaches, both receiving treatment at the same time. |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants (PIVOTAL) |
| Actual Study Start Date : | December 4, 2019 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Catheter-closure of PDA
Infants randomized to this group will undergo a catheter procedure to close hemodynamically-significant patent ductus arteriosus (HSPDA).
|
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 Name: Percutaneous closure of patent ductus arteriosus (PDA)
|
|
Active Comparator: 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.
|
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 Name: Percutaneous closure of patent ductus arteriosus (PDA)
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".
|
Outcome Measures
Primary Outcome Measures :
- Change in ventilatory support required [ 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 ]Need for ventilator support, continuous positive airway pressure (CPAP) support, or nasal cannula support
- Change in supplemental oxygen need [ 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 ]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) [ Time Frame: Through study completion, an average of 1 year ]How often (incidence) infants assigned to conservative management require intervention; failure of treatment method
Eligibility Criteria
| Ages Eligible for Study: | up to 28 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Contacts
| Contact: Carl H Backes, MD | 614-355-6729 | carl.backesjr@nationwidechildrens.org | |
| Contact: Darren Berman, MD | 614-722-4799 | darren.berman@nationwidechildrens.org |
Locations
| United States, Ohio | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Carl H Backes, MD 614-355-6729 carl.backesjr@nationwidechildrens.org | |
| Contact: Darren Berman, MD 6147224799 darren.berman@nationwidechildrens.org | |
| United States, Tennessee | |
| University of Tennessee Health Science Center | Not yet recruiting |
| Memphis, Tennessee, United States, 38163 | |
| Contact: Mark F Weems, MD 901-448-5950 mweems@uthsc.edu | |
Sponsors and Collaborators
Nationwide Children's Hospital
University of Tennessee Health Science Center
Investigators
| Principal Investigator: | Carl H Backes, MD | Nationwide Children's Hospital |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 16, 2019 | ||||||||
| First Posted Date ICMJE | June 11, 2019 | ||||||||
| Last Update Posted Date | January 27, 2021 | ||||||||
| Actual Study Start Date ICMJE | December 4, 2019 | ||||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
Need for catheter-based closure (applies to Conservative management group only) [ Time Frame: Through study completion, an average of 1 year ] How often (incidence) infants assigned to conservative management require intervention; failure of treatment method
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants | ||||||||
| Official Title ICMJE | Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants (PIVOTAL) | ||||||||
| 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. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Enrolled participants will be randomly assigned to one of two PDA treatment approaches, both receiving treatment at the same time. Masking: Single (Outcomes Assessor)Primary Purpose: Treatment |
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| Condition ICMJE | Patent Ductus Arteriosus | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
20 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 31, 2021 | ||||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
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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| Sex/Gender ICMJE |
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| Ages ICMJE | up to 28 Days (Child) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03982342 | ||||||||
| Other Study ID Numbers ICMJE | STUDY00000295 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Carl Backes, MD, Nationwide Children's Hospital | ||||||||
| Study Sponsor ICMJE | Nationwide Children's Hospital | ||||||||
| Collaborators ICMJE | University of Tennessee Health Science Center | ||||||||
| Investigators ICMJE |
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| PRS Account | Nationwide Children's Hospital | ||||||||
| Verification Date | January 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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