Patent Ductus Arteriosus
Conditions
Keywords
catheter closure, conservative treatment, percutaneous closure
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.
Interventions
DEVICECather 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.
OTHERConservative 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.
Sponsors
University of Tennessee
Nationwide Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Enrolled participants will be randomly assigned to one of two PDA treatment approaches, both receiving treatment at the same time.
Eligibility
Sex/Gender
ALL
Age
14 Days to 28 Days
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Single study participant was recruited, and informed consent documentation signed, in October of 2020 at Nationwide Children's Hospital in Columbus, Ohio.
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| 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. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Conservative Management of PDA | Total |
|---|---|---|
| Age, Continuous | 24.9 weeks | 24.9 weeks |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 |
Outcome results
Primary
Supplemental Oxygen Need
Weekly supplemental oxygen support required (in % fraction of inspired oxygen, FiO2)
Time frame: Post-randomization (up to 6 weeks) for participants in both groups.
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Conservative Management of PDA | Supplemental Oxygen Need | Enrollment | 90 percentage of oxygen |
| Conservative Management of PDA | Supplemental Oxygen Need | Week 1 | 63 percentage of oxygen |
| Conservative Management of PDA | Supplemental Oxygen Need | Week 2 | 46 percentage of oxygen |
| Conservative Management of PDA | Supplemental Oxygen Need | Week 3 | 40 percentage of oxygen |
| Conservative Management of PDA | Supplemental Oxygen Need | Week 4 | 38 percentage of oxygen |
| Conservative Management of PDA | Supplemental Oxygen Need | Week 5 | 38 percentage of oxygen |
| Conservative Management of PDA | Supplemental Oxygen Need | Week 6 | 38 percentage of oxygen |
Primary
Time on Ventilatory Support Required
Period the participant is in need of ventilator support \[Synchronized Intermittent Mandatory Ventilation (SIMV), High Frequency Oscillatory Ventilation (HFOV), or similar\]
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
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conservative Management of PDA | Time on Ventilatory Support Required | 4 weeks |
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
Time frame: 6 weeks post-randomization (to conservative management group)
Population: Single study participant enrolled continued to have a patent ductus arteriosus, ultimately qualifying for and receiving rescue intervention (catheter closure of the PDA).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conservative Management of PDA | Number of Subjects Requiring Catheter-based Closure Due to Failed Conservative Management (Applies to Conservative Management Group Only) | 1 Participants |