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PPC vs Observation for Patent Ductus Arteriosus in Infants (PIVOTAL Trial)

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
Randomization is able to be performed within 5 days of the qualifying ECHO and when infant is 7-32 days postnatal
Screening 3 weeks
Treatment Varies
Follow Up 34 - 36 weeks post-menstrual age
Awards & highlights
No Placebo-Only Group

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 below
My baby was born between 22 and 27 weeks of pregnancy.
My baby can be enrolled in the study within 5 days of their heart test, and they are 7-32 days old.

PIVOTAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~34 - 36 weeks post-menstrual age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 34 - 36 weeks post-menstrual age for reporting.

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)
+18 more
Other 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,800 Previous Clinical Trials
47,280,260 Total Patients Enrolled
Nationwide Children's HospitalLead Sponsor
334 Previous Clinical Trials
5,219,518 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,666 Previous Clinical Trials
6,694,529 Total Patients Enrolled

Media Library

PICCOLO (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05547165 — N/A
Patent Ductus Arteriosus Research Study Groups: Primary Comparator, Secondary Intervention
Patent Ductus Arteriosus Clinical Trial 2023: PICCOLO Highlights & Side Effects. Trial Name: NCT05547165 — N/A
PICCOLO (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05547165 — N/A

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
Recent research and studies
~160 spots leftby Feb 2026