Trial Outcomes & Findings for Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants (NCT NCT03982342)
NCT ID: NCT03982342
Last Updated: 2024-02-07
Results Overview
Period the participant is in need of ventilator support \[Synchronized Intermittent Mandatory Ventilation (SIMV), High Frequency Oscillatory Ventilation (HFOV), or similar\]
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
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
Results posted on
2024-02-07
Participant Flow
Single study participant was recruited, and informed consent documentation signed, in October of 2020 at Nationwide Children's Hospital in Columbus, Ohio.
Participant milestones
| Measure |
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.
|
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".
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants
Baseline characteristics by cohort
| Measure |
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.
|
Conservative Management of PDA
n=1 Participants
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".
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
—
|
24.9 weeks
n=4 Participants
|
24.9 weeks
n=27 Participants
|
|
Sex: Female, Male
Female
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
—
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
—
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 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 agePopulation: 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.
Period the participant is in need of ventilator support \[Synchronized Intermittent Mandatory Ventilation (SIMV), High Frequency Oscillatory Ventilation (HFOV), or similar\]
Outcome measures
| Measure |
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.
|
Conservative Management of PDA
n=1 Participants
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".
|
|---|---|---|
|
Time on Ventilatory Support Required
|
—
|
4 weeks
|
PRIMARY outcome
Timeframe: 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).
Weekly supplemental oxygen support required (in % fraction of inspired oxygen, FiO2)
Outcome measures
| Measure |
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.
|
Conservative Management of PDA
n=1 Participants
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".
|
|---|---|---|
|
Supplemental Oxygen Need
Enrollment
|
—
|
90 percentage of oxygen
|
|
Supplemental Oxygen Need
Week 1
|
—
|
63 percentage of oxygen
|
|
Supplemental Oxygen Need
Week 2
|
—
|
46 percentage of oxygen
|
|
Supplemental Oxygen Need
Week 3
|
—
|
40 percentage of oxygen
|
|
Supplemental Oxygen Need
Week 4
|
—
|
38 percentage of oxygen
|
|
Supplemental Oxygen Need
Week 5
|
—
|
38 percentage of oxygen
|
|
Supplemental Oxygen Need
Week 6
|
—
|
38 percentage of oxygen
|
SECONDARY outcome
Timeframe: 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).
How often (incidence) infants assigned to conservative management require intervention; failure of treatment method
Outcome measures
| Measure |
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.
|
Conservative Management of PDA
n=1 Participants
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".
|
|---|---|---|
|
Number of Subjects Requiring Catheter-based Closure Due to Failed Conservative Management (Applies to Conservative Management Group Only)
|
—
|
1 Participants
|
Adverse Events
Catheter-closure of PDA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conservative Management of PDA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place