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Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants (PIVOTAL)

Primary Purpose

Ductus Arteriosus, Patent

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous Patent Ductus Arteriosus Closure (PPC)
Responsive Management Intervention
Echocardiogram, cardiac
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ductus Arteriosus, Patent focused on measuring PDA

Eligibility Criteria

7 Days - 32 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. EPIs born between 22-weeks+0 days (220/7 wks) and 27-weeks+6 days (276/7 wks) gestation, inclusive
  2. Admitted to a study NICU
  3. Birth weight ≥700-grams
  4. Mechanically ventilated at time of consent and randomization
  5. HSPDA ("PDA Score" ≥6) noted on echocardiogram (ECHO)
  6. Randomization is able to be performed within 5 days of the qualifying ECHO and when infant is 7-32 days postnatal

Exclusion Criteria:

Clinical Exclusion Criteria

  1. Life-threatening congenital defects (including congenital heart disease such as aortic coarctation or pulmonary artery stenosis). PDA and small atrial/ventricular septal defects are permitted;
  2. Congenital lung abnormalities, (e.g. restrictive lung disease);
  3. Pharyngeal or airway anomalies (tracheal stenosis, choanal atresia);
  4. Treatment for acute abdominal process (e.g., necrotizing enterocolitis);
  5. Infants with planned surgery;
  6. Active infection requiring treatment;
  7. Chromosomal defects (e.g., Trisomy 18);
  8. Neuromuscular disorders;
  9. Infants whose parents have chosen to allow natural death (do not resuscitate order) or for whom limitation of intensive care treatment is being considered (e.g. severe intraventricular hemorrhage)
  10. Physician deems that the infant would not be a Percutaneous PDA Closure candidate due to clinical instability; however, if the infant's clinical status improves before 30-days postnatal and all inclusion criteria are still met, then the infant may be enrolled.

ECHO-based Exclusion Criteria

  1. Pulmonary hypertension (defined by ductal right to left shunting for >33% of the cardiac cycle) in which early PDA closure may increase right ventricular afterload and compromise pulmonary and systemic blood flow;
  2. Evidence of cardiac thrombus that might interfere with device placement;
  3. PDA diameter larger than 4 mm at the narrowest portion (consistent with FDA-approved instructions for Piccolo™ device use).
  4. PDA length smaller than 3 mm (consistent with FDA-approved instructions for Piccolo™ device use).
  5. PDA that does not meet inclusion requirements ("PDA Score" <6).* * If a potential participant is found to have a PDA meeting eligibility requirements on a subsequent ECHO during the required period of 7 - 30 postnatal days of age, they may then be declared eligible to participate and enrolled, provided all other inclusion criteria are met and exclusion criteria are not met.

Other Exclusion Criteria

1. Parents or legal guardian do not speak English or Spanish

Sites / Locations

  • Arkansas Children's Hospital
  • Children's Hospital Los Angeles
  • Cedars-Sinai Medical Center
  • Lucille Packard Children's Hospital at Stanford
  • UC Davis Children's Hospital
  • Children's Hospital Colorado
  • Joe DiMaggio Children's Hospital
  • Arnold Palmer Hospital for Children
  • Ann and Robert H. Lurie Children's Hospital
  • Boston Children's Hospital
  • C.S. Mott Children's Hospital
  • M Health Fairview University of Minnesota Masonic Children's Hospital
  • St. Louis Children's Hospital
  • Morgan Stanley Children's Hospital of New York-Presbyterian
  • Cincinnati Children's Hospital Medical Center
  • Nationwide Children's HospitalRecruiting
  • Children's Hospital of Philadelphia
  • Le Bonheur Children's Medical Center
  • Monroe Carell Jr. Children's Hospital at Vanderbilt
  • Medical City Children's Hospital
  • UT Southwestern Children's Medical Center of Dallas
  • Seattle Children's
  • Children's Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Primary Comparator

Secondary Intervention

Arm Description

Interventional groups that subject will be randomly assigned to include Percutaneous Patent Ductus Arteriosus Closure (PPC) or Responsive Management. Those assigned to PPC will undergo active intervention to close a hemodynamically significant patent ductus arteriosus (HSPDA) whereas those assigned to Responsive Management will be treated to manage the symptoms of the HSPDA and permit natural closure over time.

Sub-group of patients initially randomized to Responsive Management who may suffer a decline in health status that can be attributed to the presence of a hemodynamically significant patent ductus arteriosus (HSPDA). These patients, upon meeting pre-specified clinical criteria, will undergo active treatment via Percutaneous Patent Ductus Arteriosus Closure (PPC) as in the active comparator arm.

Outcomes

Primary Outcome Measures

Number of days free of ventilatory support requirement (ventilator-free days; VFDs)
Ventilator free days (VFDs) are defined as the number of days that a subject is alive and free from mechanical ventilatory support. VFDs are an established respiratory outcome measure in pediatric clinical trials, and are a strong predictor of short-term and longer-term oucomes, including length of neonatal intensive care unit (NICU) stay, morbidities, and mortality.

Secondary Outcome Measures

Positive-pressure dependency or death
A composite outcome measure (yes/no), positive pressure dependency at 36 weeks post-menstrual age (PMA) is an indicator of chronic lung disease (CLD), the most common and serious respiratory complication of prematurity. Both invasive and non-invasive positive pressure ventilation at 36 weeks PMA is associated with long-term respiratory and neurodevelopmental impairment.
Diagnosis of pulmonary hypertension or death
A compositve binary outcome measure (yes/no), diagnosis of pulmonary hypertension will be determined by cardiac echocardiogram at 36 weeks post-menstrual age. Diagnosis of pulmonary hypertension is an indicator of increased pulmonary vasculature resistance, a marker for increased morbidity and mortality among infants with chronic lung disease.
Total days on mechanical ventilation
The total number of days (continuous variable) a study subject requires any use of invasive mechanical ventilatory support within a 24-hour calendar day.
Days requiring positive-pressure assisted breathing
The sum of days the study subject requires either invasive or non-invasive positive pressure assisted ventilation within a 24 hour calendar day.
Days on supplemental oxygen
Total number of days the study subject requires supplemental oxygen. The subject may be on either invasive or non-invasive ventilatory support during this time. The subject must be free from supplemental oxygen use for a period of at least 24 hours to interrupt or cease counting.
Time to death
A continuous measure, in days, of the time from a study subject's randomization to expiration, if this occurs.
Diagnosis of cardiac dysfunction
A diagnosis of left-ventricular output by echocardiography (ECHO) at 36 weeks post-menstrual age.
Abnormal cardiac remodeling
Finding of left-ventricular end-diastolic volume (LV EDV) >97% on echocardiography (ECHO) at 36 weeks post-menstrual age.
General Movements Assessment (GMA)
The General Movements Assessment (GMA) is a standardized video-based neurological exam to evaluate the presence of "fidgety" versus "absent fidgety" and "cramped-synchronized" versus "non cramped-synchronized" movement patterns at 34 - 36 weeks post-menstrual age. It is used to assist in the diagnosis of impaired motor neurodevelopment and cerebral palsy.
Need for rescue intervention
Recording of incidence of need for study subjects randomized to Responsive Management to undergo Percutaneous Patent Ductus Arteriosus Closure (PPC) due to decline in health status.
Hammersmith Neonatal Neurological Examination (HNNE)
The HNNE is a standardized neurological examination of 34 items to evaluate tone, motor patterns, spontaneous movements, reflexes, visual and auditory attention, and behavior.
Hammersmith Infant Neurological Examination (HINE)
The HINE is similar to the HNNE, used to assess neurological function at 3 - 24 months of age, including cranial nerve function, movements, reflexes, protective reactions and behavior, and age-dependent evaluation of gross and fine-motor function.
Infant/Toddler Sensory Profile (Low Registration Domain)
Caregiver questionnaire responses to determine if their infant appropriately processes and responds to environmental stimuli, versus missing or taking longer to respond ("Low Registration"). There are 13 items with scores of 13 - 65 possible; scores of 42 - 51 are considered "Typical performance".
Infant/Toddler Sensory Profile (Sensation Seeking Domain)
Caregiver questionnaire responses to determine if their infant is hyposensitive, seeking additional sensory stimulation. There are 6 items with scores of 6 - 30 possible; scores of 7 - 15 are considered "Typical performance".
Infant/Toddler Sensory Profile (Sensory Sensitivity Domain)
Caregiver questionnaire responses to determine if their infant responds readily to sensory stimulation, without actively avoiding it. There are 12 items with scores of 12 - 60 possible; scores of 45 - 57 are considered "Typical performance)
Infant/Toddler Sensory Profile (Sensation Avoiding Domain)
Caregiver questionnaire responses to determine if their infant avoids sensory stimulation. There are 5 items with scores of 5 - 25 possible; scores of 19 - 25 are considered "Typical performance".
Infant/Toddler Sensory Profile (Low Threshold Domain)
Caregiver questionnaire responses which are the sum of the Sensory Sensitivity and Sensation Avoiding domains). Summed scores of 15 - 85 are possible; summed scores of 64 - 81 are considered "Typical performance".
Baby Care Questionnaire (BCQ)
The BCQ is another caregiver-based questionnaire for parental perspectives of an infant's feeding and sleeping habits. It is used as an evaluation of a parent's reliance upon structure / routines and attunement (dependence upon infant's cues).
Mother-Infant Bonding Scale (MIBS)
The MIBS is an 8-item questionnaire to evaluate a mother's bondedness towards her infant. Responses are scored from 0 to 3 for each item, with a total possible range of 0 - 24. Lower scores indicate more favorable outcomes for mother-infant bondedness, whereas higher scores indicate the potential for difficulties.
Type and incidence of any adverse event
Reporting of type and frequency of any adverse event that occurs during percutaneous closure procedures, and post-procedurally that may be related to the intervention.
Type and incidence of serious adverse event
Reporting of type and frequency of any serious adverse event (e.g., potentially life-threatening change in status) that occurs during percutaneous closure procedures, and post-procedurally that may be related to the intervention.

Full Information

First Posted
August 30, 2022
Last Updated
March 21, 2023
Sponsor
Nationwide Children's Hospital
Collaborators
National Institutes of Health (NIH), Abbott, University of Pittsburgh, University of Bristol, Dartmouth College, University of Iowa, Emory University, Cedars-Sinai Medical Center, Children's Hospital Los Angeles, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05547165
Brief Title
Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants
Acronym
PIVOTAL
Official Title
Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
Collaborators
National Institutes of Health (NIH), Abbott, University of Pittsburgh, University of Bristol, Dartmouth College, University of Iowa, Emory University, Cedars-Sinai Medical Center, Children's Hospital Los Angeles, National Heart, Lung, and Blood Institute (NHLBI)

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
Yes

5. Study Description

Brief Summary
Patent Ductus Arteriosus is a developmental condition commonly observed among preterm infants. It is a condition where the opening between the two major blood vessels leading from the heart fail to close after birth. In the womb, the opening (ductus arteriosus) is the normal part of the circulatory system of the baby, but is expected to close at full term birth. If the opening is tiny, the condition can be self-limiting. If not, medications/surgery are options for treatment. There are two ways to treat patent ductus arteriosus - one is through closure of the opening with an FDA approved device called PICCOLO, the other is through supportive management (medications). No randomized controlled trials have been done previously to see if one of better than the other. Through our PIVOTAL study, the investigators aim to determine is one is indeed better than the other - if it is found that the percutaneous closure with PICCOLO is better, then it would immediately lead to a new standard of care. If not, then the investigators avoid an invasive costly procedure going forward.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductus Arteriosus, Patent
Keywords
PDA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary Comparator
Arm Type
Active Comparator
Arm Description
Interventional groups that subject will be randomly assigned to include Percutaneous Patent Ductus Arteriosus Closure (PPC) or Responsive Management. Those assigned to PPC will undergo active intervention to close a hemodynamically significant patent ductus arteriosus (HSPDA) whereas those assigned to Responsive Management will be treated to manage the symptoms of the HSPDA and permit natural closure over time.
Arm Title
Secondary Intervention
Arm Type
Other
Arm Description
Sub-group of patients initially randomized to Responsive Management who may suffer a decline in health status that can be attributed to the presence of a hemodynamically significant patent ductus arteriosus (HSPDA). These patients, upon meeting pre-specified clinical criteria, will undergo active treatment via Percutaneous Patent Ductus Arteriosus Closure (PPC) as in the active comparator arm.
Intervention Type
Device
Intervention Name(s)
Percutaneous Patent Ductus Arteriosus Closure (PPC)
Intervention Description
Infants in this group will undergo catheter-based PPC closure ≤48 hours following randomization and within 7-days of qualifying ECHO. All participants assigned to PPC will receive the Amplatzer Piccolo™ Occluder which will be implanted within the duct (intraductal placement). The Piccolo™ occluder is approved by the US FDA for this purpose.
Intervention Type
Combination Product
Intervention Name(s)
Responsive Management Intervention
Intervention Description
Interventional PDA-closure, including PPC or surgical ligation and post-randomization pharmacologic (NSAID or acetaminophen) (enteral or intravenous) PDA treatment, are not allowed unless secondary treatment thresholds (see below) are met. Healthcare decisions for Responsive Management will be made at the discretion of the treatment team, while the infant is carefully monitored for any decline in status that may be attributed to the presence of PDA, in which case, Secondary Intervention (described below) may be considered. Despite widespread acceptance of responsive PDA management, no consensus definition exists. The following Responsive Management interventions are permitted but not required per clinician discretion: 1) fluid restriction between 120-140 mL/kg/day; 2) diuretics (per local practice); 3) increases in positive end-expiratory pressure (PEEP).
Intervention Type
Diagnostic Test
Intervention Name(s)
Echocardiogram, cardiac
Intervention Description
An echocardiogram, also known as "ECHO", is an ultrasound image of the heart. Echocardiography is a common test used for the diagnosis and management of cardiac diseases or conditions.
Primary Outcome Measure Information:
Title
Number of days free of ventilatory support requirement (ventilator-free days; VFDs)
Description
Ventilator free days (VFDs) are defined as the number of days that a subject is alive and free from mechanical ventilatory support. VFDs are an established respiratory outcome measure in pediatric clinical trials, and are a strong predictor of short-term and longer-term oucomes, including length of neonatal intensive care unit (NICU) stay, morbidities, and mortality.
Time Frame
30 days post-randomization
Secondary Outcome Measure Information:
Title
Positive-pressure dependency or death
Description
A composite outcome measure (yes/no), positive pressure dependency at 36 weeks post-menstrual age (PMA) is an indicator of chronic lung disease (CLD), the most common and serious respiratory complication of prematurity. Both invasive and non-invasive positive pressure ventilation at 36 weeks PMA is associated with long-term respiratory and neurodevelopmental impairment.
Time Frame
36 weeks post-menstrual age
Title
Diagnosis of pulmonary hypertension or death
Description
A compositve binary outcome measure (yes/no), diagnosis of pulmonary hypertension will be determined by cardiac echocardiogram at 36 weeks post-menstrual age. Diagnosis of pulmonary hypertension is an indicator of increased pulmonary vasculature resistance, a marker for increased morbidity and mortality among infants with chronic lung disease.
Time Frame
36 weeks post-menstrual age
Title
Total days on mechanical ventilation
Description
The total number of days (continuous variable) a study subject requires any use of invasive mechanical ventilatory support within a 24-hour calendar day.
Time Frame
4 months corrected age
Title
Days requiring positive-pressure assisted breathing
Description
The sum of days the study subject requires either invasive or non-invasive positive pressure assisted ventilation within a 24 hour calendar day.
Time Frame
Randomization through 4 months corrected age
Title
Days on supplemental oxygen
Description
Total number of days the study subject requires supplemental oxygen. The subject may be on either invasive or non-invasive ventilatory support during this time. The subject must be free from supplemental oxygen use for a period of at least 24 hours to interrupt or cease counting.
Time Frame
Randomization through 4 months corrected age
Title
Time to death
Description
A continuous measure, in days, of the time from a study subject's randomization to expiration, if this occurs.
Time Frame
Randomization through 4 months corrected age
Title
Diagnosis of cardiac dysfunction
Description
A diagnosis of left-ventricular output by echocardiography (ECHO) at 36 weeks post-menstrual age.
Time Frame
36 weeks post-menstrual age
Title
Abnormal cardiac remodeling
Description
Finding of left-ventricular end-diastolic volume (LV EDV) >97% on echocardiography (ECHO) at 36 weeks post-menstrual age.
Time Frame
36 weeks post-menstrual age
Title
General Movements Assessment (GMA)
Description
The General Movements Assessment (GMA) is a standardized video-based neurological exam to evaluate the presence of "fidgety" versus "absent fidgety" and "cramped-synchronized" versus "non cramped-synchronized" movement patterns at 34 - 36 weeks post-menstrual age. It is used to assist in the diagnosis of impaired motor neurodevelopment and cerebral palsy.
Time Frame
34 - 36 weeks post-menstrual age
Title
Need for rescue intervention
Description
Recording of incidence of need for study subjects randomized to Responsive Management to undergo Percutaneous Patent Ductus Arteriosus Closure (PPC) due to decline in health status.
Time Frame
Randomization through 4 months corrected age
Title
Hammersmith Neonatal Neurological Examination (HNNE)
Description
The HNNE is a standardized neurological examination of 34 items to evaluate tone, motor patterns, spontaneous movements, reflexes, visual and auditory attention, and behavior.
Time Frame
34 - 36 weeks post-menstrual age
Title
Hammersmith Infant Neurological Examination (HINE)
Description
The HINE is similar to the HNNE, used to assess neurological function at 3 - 24 months of age, including cranial nerve function, movements, reflexes, protective reactions and behavior, and age-dependent evaluation of gross and fine-motor function.
Time Frame
3 - 4 months of corrected age
Title
Infant/Toddler Sensory Profile (Low Registration Domain)
Description
Caregiver questionnaire responses to determine if their infant appropriately processes and responds to environmental stimuli, versus missing or taking longer to respond ("Low Registration"). There are 13 items with scores of 13 - 65 possible; scores of 42 - 51 are considered "Typical performance".
Time Frame
3 - 4 months of corrected age
Title
Infant/Toddler Sensory Profile (Sensation Seeking Domain)
Description
Caregiver questionnaire responses to determine if their infant is hyposensitive, seeking additional sensory stimulation. There are 6 items with scores of 6 - 30 possible; scores of 7 - 15 are considered "Typical performance".
Time Frame
3 - 4 months of corrected age
Title
Infant/Toddler Sensory Profile (Sensory Sensitivity Domain)
Description
Caregiver questionnaire responses to determine if their infant responds readily to sensory stimulation, without actively avoiding it. There are 12 items with scores of 12 - 60 possible; scores of 45 - 57 are considered "Typical performance)
Time Frame
3 - 4 months of corrected age
Title
Infant/Toddler Sensory Profile (Sensation Avoiding Domain)
Description
Caregiver questionnaire responses to determine if their infant avoids sensory stimulation. There are 5 items with scores of 5 - 25 possible; scores of 19 - 25 are considered "Typical performance".
Time Frame
3 - 4 months of corrected age
Title
Infant/Toddler Sensory Profile (Low Threshold Domain)
Description
Caregiver questionnaire responses which are the sum of the Sensory Sensitivity and Sensation Avoiding domains). Summed scores of 15 - 85 are possible; summed scores of 64 - 81 are considered "Typical performance".
Time Frame
3 - 4 months of corrected age
Title
Baby Care Questionnaire (BCQ)
Description
The BCQ is another caregiver-based questionnaire for parental perspectives of an infant's feeding and sleeping habits. It is used as an evaluation of a parent's reliance upon structure / routines and attunement (dependence upon infant's cues).
Time Frame
3 - 4 months of corrected age
Title
Mother-Infant Bonding Scale (MIBS)
Description
The MIBS is an 8-item questionnaire to evaluate a mother's bondedness towards her infant. Responses are scored from 0 to 3 for each item, with a total possible range of 0 - 24. Lower scores indicate more favorable outcomes for mother-infant bondedness, whereas higher scores indicate the potential for difficulties.
Time Frame
3 - 4 months of corrected age
Title
Type and incidence of any adverse event
Description
Reporting of type and frequency of any adverse event that occurs during percutaneous closure procedures, and post-procedurally that may be related to the intervention.
Time Frame
3 - 4 months of corrected age
Title
Type and incidence of serious adverse event
Description
Reporting of type and frequency of any serious adverse event (e.g., potentially life-threatening change in status) that occurs during percutaneous closure procedures, and post-procedurally that may be related to the intervention.
Time Frame
3 - 4 months of corrected age
Other Pre-specified Outcome Measures:
Title
Determine whether neurodevelopment at 3-4 months CA is mediated by improved neurodevelopmental profiles at 34-36 weeks PMA.
Description
Analysis of HNNE / HINE scores to determine if neurodevelopmental evaluation scores conducted at 34 - 36 weeks post-menstrual age mediate outcomes at 3 - 4 months corrected age
Time Frame
34-36 weeks post-menstrual age and 3 - 4 months corrected age
Title
Evaluation of effect modifiers on primary and secondary outcomes
Description
Examination of the homogeneity of the effect of HSPDA on the primary and secondary outcomes will be carried out in statistical analyses using stratification variables (e.g., gender, gestational age, etc.) and characteristics not balanced through random assignment, if any such imbalances are found.
Time Frame
Birth to 4 months of corrected age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
32 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: EPIs born between 22-weeks+0 days (220/7 wks) and 27-weeks+6 days (276/7 wks) gestation, inclusive Admitted to a study NICU Birth weight ≥700-grams Mechanically ventilated at time of consent and randomization HSPDA ("PDA Score" ≥6) noted on echocardiogram (ECHO) Randomization is able to be performed within 5 days of the qualifying ECHO and when infant is 7-32 days postnatal Exclusion Criteria: Clinical Exclusion Criteria Life-threatening congenital defects (including congenital heart disease such as aortic coarctation or pulmonary artery stenosis). PDA and small atrial/ventricular septal defects are permitted; Congenital lung abnormalities, (e.g. restrictive lung disease); Pharyngeal or airway anomalies (tracheal stenosis, choanal atresia); Treatment for acute abdominal process (e.g., necrotizing enterocolitis); Infants with planned surgery; Active infection requiring treatment; Chromosomal defects (e.g., Trisomy 18); Neuromuscular disorders; Infants whose parents have chosen to allow natural death (do not resuscitate order) or for whom limitation of intensive care treatment is being considered (e.g. severe intraventricular hemorrhage) Physician deems that the infant would not be a Percutaneous PDA Closure candidate due to clinical instability; however, if the infant's clinical status improves before 30-days postnatal and all inclusion criteria are still met, then the infant may be enrolled. ECHO-based Exclusion Criteria Pulmonary hypertension (defined by ductal right to left shunting for >33% of the cardiac cycle) in which early PDA closure may increase right ventricular afterload and compromise pulmonary and systemic blood flow; Evidence of cardiac thrombus that might interfere with device placement; PDA diameter larger than 4 mm at the narrowest portion (consistent with FDA-approved instructions for Piccolo™ device use). PDA length smaller than 3 mm (consistent with FDA-approved instructions for Piccolo™ device use). PDA that does not meet inclusion requirements ("PDA Score" <6).* * If a potential participant is found to have a PDA meeting eligibility requirements on a subsequent ECHO during the required period of 7 - 30 postnatal days of age, they may then be declared eligible to participate and enrolled, provided all other inclusion criteria are met and exclusion criteria are not met. Other Exclusion Criteria 1. Parents or legal guardian do not speak English or Spanish
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carl H Backes
Phone
16143556729
Email
carl.backes@nationwidechildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Slaughter
Phone
16143556643
Email
jonathan.slaughter@nationwidechildrens.org
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megha Sharma, MD
Email
MSharma@uams.edu
First Name & Middle Initial & Last Name & Degree
Sherry Courtney, MD
Email
SECourtney@uams.edu
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darren Berman, MD
Email
dberman@chla.usc.edu
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evan Zahn, MD
Email
Evan.Zahn@cshs.org
First Name & Middle Initial & Last Name & Degree
Kurlen Payton, MD
Email
Kurlen.Payton@cshs.org
Facility Name
Lucille Packard Children's Hospital at Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynn Peng, MD
Email
lynnpeng@stanford.edu
First Name & Middle Initial & Last Name & Degree
Valerie Chock, MD
Email
vchock@stanford.edu
Facility Name
UC Davis Children's Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Ing, MD
Email
ffing@ucdavis.edu
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theresa Grover, MD
Email
Theresa.Grover@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Gareth Morgan, MD
Email
drgarethjmorgan@gmail.com
Facility Name
Joe DiMaggio Children's Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Guyton, MD
Email
PGuyon@mhs.net
First Name & Middle Initial & Last Name & Degree
Bruce Schulman, MD
Email
Brucesmd@aol.com
Facility Name
Arnold Palmer Hospital for Children
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael McMahan, MD
Email
Michael.McMahan@orlandohealth.com
First Name & Middle Initial & Last Name & Degree
Michael Farias, MD
Email
michael.farias@orlandohealth.com
Facility Name
Ann and Robert H. Lurie Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shawn Sen, MD
Email
ssen@luriechildrens.org
First Name & Middle Initial & Last Name & Degree
Alan Nugent, MD
Email
anugent@luriechildrens.org
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Levy, MD
Email
philip.levy@childrens.harvard.edu
Facility Name
C.S. Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meera Meerkov, MD
Email
mmeerkov@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Jeff Zampi, MD
Email
jzampi@med.umich.edu
Facility Name
M Health Fairview University of Minnesota Masonic Children's Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Engel, MD
Email
wayn0020@umn.edu
First Name & Middle Initial & Last Name & Degree
Gurumurthy Hiremath, MD
Email
hiremath@umn.edu
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andy Glatz, MD
Email
glatz@wustl.edu
First Name & Middle Initial & Last Name & Degree
Shawn Connor, MD
Email
soconnor@wustl.edu
Facility Name
Morgan Stanley Children's Hospital of New York-Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ganga Krishnamurthy, MD
Email
gk2008@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Tina Leone, MD
Email
tal2132@cumc.columbia.edu
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shabana Shahanavaz, MD
Email
shabana.shahanavaz@cchmc.org
First Name & Middle Initial & Last Name & Degree
Melissa House, MD
Email
Melissa.House@cchmc.org
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Slaughter, MD
Email
Jonathan.Slaughter@nationwidechildrens.org
First Name & Middle Initial & Last Name & Degree
Carl Backes, MD
Email
Carl.Backes@nationwidechildrens.org
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Gillespie, MD
Email
GILLESPIE@email.chop.edu
Facility Name
Le Bonheur Children's Medical Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Weems, MD
Email
mweems@uthsc.edu
Facility Name
Monroe Carell Jr. Children's Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff Reese, MD
Email
jeff.reese@vumc.org
First Name & Middle Initial & Last Name & Degree
George Nicholson, MD
Email
george.t.nicholson@vumc.org
Facility Name
Medical City Children's Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
V. Vivian Dimas, MD
Email
vivian.dimas@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Carrie Herbert, MD
Email
Carrie.Herbert@hcahealthcare.com
Facility Name
UT Southwestern Children's Medical Center of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sushmita Yallapragada, MD
Email
Sushmita.Yallapragada@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Suren Reddy, MD
Email
suren.reddy@utsouthwestern.edu
Facility Name
Seattle Children's
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Morray, MD
Email
brian.morray@seattlechildrens.org
First Name & Middle Initial & Last Name & Degree
Robert DiGeronimo, MD
Email
robert.digeronimo@seattlechildrens.org
Facility Name
Children's Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vijay Karody, MD
Email
vkarody@mcw.edu
First Name & Middle Initial & Last Name & Degree
Todd Gudausky, MD
Email
dgudausk@mcw.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants

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