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PPC vs Observation for Patent Ductus Arteriosus in Infants (PIVOTAL Trial)
N/A
Recruiting
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
EPIs born between 22-weeks+0 days (220/7 wks) and 27-weeks+6 days (276/7 wks) gestation, inclusive
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 34 - 36 weeks post-menstrual age
Awards & highlights
PIVOTAL Trial Summary
This trial is a randomized controlled trial, which is the best way to determine if one treatment is better than the other.
Who is the study for?
This trial is for preterm infants with Patent Ductus Arteriosus (PDA), a heart condition present at birth. Eligible infants must be in the NICU, on mechanical ventilation, and between 7-32 days old with a birth weight of ≥700 grams. They should have a specific PDA severity score on an echocardiogram but no chromosomal defects, neuromuscular disorders, congenital lung abnormalities or life-threatening conditions.Check my eligibility
What is being tested?
The study compares two treatments for PDA: percutaneous closure using the PICCOLO device versus supportive management with medications. It's designed to see which method is more effective for these low-weight infants and could potentially set new care standards.See study design
What are the potential side effects?
Potential side effects are not explicitly listed in the provided information; however, as it involves an invasive procedure (PPC) using PICCOLO or medication management, risks may include infection, bleeding, or reactions to anesthesia/medications.
PIVOTAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My baby was born between 22 and 27 weeks of pregnancy.
PIVOTAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 34 - 36 weeks post-menstrual age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~34 - 36 weeks post-menstrual age
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ventilator - respiratory equipment
Secondary outcome measures
Abnormal cardiac remodeling
Baby Care Questionnaire (BCQ)
Oxygen
+18 moreOther outcome measures
Determine whether neurodevelopment at 3-4 months CA is mediated by improved neurodevelopmental profiles at 34-36 weeks PMA.
Evaluation of effect modifiers on primary
PIVOTAL Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Secondary InterventionExperimental Treatment2 Interventions
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.
Group II: Primary ComparatorActive Control3 Interventions
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.
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Who is running the clinical trial?
AbbottIndustry Sponsor
751 Previous Clinical Trials
477,935 Total Patients Enrolled
Emory UniversityOTHER
1,640 Previous Clinical Trials
2,560,456 Total Patients Enrolled
University of BristolOTHER
107 Previous Clinical Trials
25,022,057 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My infant is under a do not resuscitate order or we are considering limiting intensive care.My baby can be enrolled in the study within 5 days of their heart test, and they are 7-32 days old.My baby was born between 22 and 27 weeks of pregnancy.I have a genetic condition like Trisomy 18.I have a blood clot in my heart that could affect medical device placement.I have high blood pressure in the lungs due to a heart issue.I have a serious birth defect, but not a small hole in my heart.You weighed at least 700 grams (about 1.5 pounds) at birth.My parents or guardian do not speak English or Spanish.Your PDA (patent ductus arteriosus) is larger than 4 mm at its narrowest part.You have a high score on an echocardiogram (ECHO) test called the "PDA Score."My infant is scheduled for surgery.I have a throat or airway abnormality.My PDA score is below 6 but can be re-evaluated for eligibility between 7-30 days after birth.The length of your PDA (patent ductus arteriosus) is less than 3 millimeters, which is not suitable for using the Piccolo™ device according to FDA guidelines.My baby is currently too unstable for a specific heart procedure but could be eligible if their condition improves within 30 days of birth.I have a disorder affecting my muscles and nerves.I was born with a lung condition.I am currently being treated for an infection.I am receiving treatment for a severe abdominal condition.
Research Study Groups:
This trial has the following groups:- Group 1: Primary Comparator
- Group 2: Secondary Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do you accept participants who are over fifty years of age for this examination?
"This research requires participants who are between 7 and 32 years of age."
Answered by AI
Is there a possibility of my participation in this clinical trial?
"This study seeks to enrol 240 neonates between 7 and 32 days of age with a patent ductus arteriosus. To qualify, infants must have been born within the 22-week+0 day (220/7 weeks) through 27-weeks+6 day (276/7 weeks) gestational window; weigh at least 700 grams; be mechanically ventilated when consenting and randomizing; exhibit an ECHO score of 6 or greater on their HSPDA ("PDA Score"); and randomization must occur within 5 days postnatal from obtaining the qualifying ECHO."
Answered by AI
Which Canadian health care centers have been assigned to this medical investigation?
"At present, 23 sites are permitting the enrollment of patients. These include Seattle, Sacramento and Ann Arbor along with 20 additional cities. To minimize travel costs associated with participation in this study it is advisable to enroll at a site near your residence."
Answered by AI
Are there any vacant spots available for participants in this experiment?
"As per the information provided on clinicaltrials.gov, this medical research is not in need of participants at present time. Initially posted March 1st 2023 and last updated September 15th 2022, there are currently 14 other investigations recruiting volunteers."
Answered by AI
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