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Nonsteroidal Anti-inflammatory Drug

Ibuprofen for Patent Ductus Arteriosus (SMART-PDA Trial)

Phase 3
Recruiting
Led By Souvik Mitra, MD, MSc
Research Sponsored by IWK Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Preterm infants less than 26 completed weeks (i.e., up to and including 25 weeks and 6 days) of gestation
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up birth through 36 weeks post menstrual age
Awards & highlights

SMART-PDA Trial Summary

This trial will assess the feasibility of a large study exploring whether early treatment of a symptomatic PDA is beneficial for preterm infants born <26 weeks gestation.

Who is the study for?
This trial is for preterm infants born before completing 26 weeks of gestation and diagnosed with Patent Ductus Arteriosus (PDA). Infants without PDA, those with significant congenital heart disease or other major anomalies, or if there's a decision to withhold care are excluded.Check my eligibility
What is being tested?
The study tests whether giving Ibuprofen early on to extremely premature babies with PDA is beneficial compared to no treatment. Babies will be randomly assigned to either receive the drug early or not in their first week of life.See study design
What are the potential side effects?
Ibuprofen may cause side effects such as potential harm to the gut and kidneys in these very young patients. The exact side effects will be closely monitored due to the vulnerability of this age group.

SMART-PDA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby was born before completing 26 weeks of pregnancy.

SMART-PDA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through hospital discharge (approximately 20 weeks postnatal age unless death occurs first) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of eligible infants recruited during the study period
Proportion of randomized infants with no reported protocol deviations
Secondary outcome measures
All-cause mortality during hospital stay
Chronic lung disease
Completeness of data collection for clinical outcomes
+19 more

SMART-PDA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Selective early medical treatment (SMART) strategyExperimental Treatment1 Intervention
Infants who are randomized to experimental group will follow the SMART treatment protocol, which includes echocardiographic screening every 72 hours to categorize PDA disease severity by combining clinical and echocardiographic features. At any evaluation if patients are found to have a "severe PDA" on echocardiography, irrespective of clinical symptoms, or a "moderate PDA" on echocardiography with at least moderate clinical illness, they will receive pharmacotherapy aimed at PDA closure (The PDA severity has been divided into mild, moderate or severe based on pre-defined clinical and echocardiographic criteria).
Group II: Early conservative management strategyActive Control1 Intervention
Infants randomized to this arm will not undergo any further echocardiographic assessment or pharmacological treatment of the PDA regardless of the clinical signs. If the infant gets an echocardiographic assessment for a reason different than PDA assessment (such as hypotension or oxygenation failure) and a PDA is incidentally noted that fits the treatment criteria, the infant will not be initiated on pharmacotherapy. After 7 days of age, decision on PDA assessment and treatment will be at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibuprofen
2013
Completed Phase 4
~5800

Find a Location

Who is running the clinical trial?

BC Children's Hospital Research InstituteOTHER
12 Previous Clinical Trials
2,242 Total Patients Enrolled
Sunnybrook Health Sciences CentreOTHER
656 Previous Clinical Trials
1,551,342 Total Patients Enrolled
Mount Sinai Hospital, CanadaOTHER
196 Previous Clinical Trials
67,508 Total Patients Enrolled

Media Library

Ibuprofen (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05011149 — Phase 3
Patent Ductus Arteriosus Research Study Groups: Selective early medical treatment (SMART) strategy, Early conservative management strategy
Patent Ductus Arteriosus Clinical Trial 2023: Ibuprofen Highlights & Side Effects. Trial Name: NCT05011149 — Phase 3
Ibuprofen (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05011149 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many hospitals is this trial currently being conducted?

"There are 8 clinical trial sites available for this study, located at hospitals including Stollery Children's Hospital in Edmonton, British Columbia Women's Hospital in Vancouver, and Mount Sinai Hospital in Toronto."

Answered by AI

What are the dangers of Ibuprofen for patients?

"Ibuprofen's safety is well-documented, as it has progressed to Phase 3 clinical trials. This over-the-counter medication receives a score of 3 from our team."

Answered by AI

How many patients are enrolled in this clinical research?

"In order to move forward, this clinical trial requires 100 individuals that match the pre-determined inclusion criteria. These potential participants can be located at different hospitals such as Stollery Children's Hospital in Edmonton, Alberta or British Columbia Women's Hospital in Vancouver, British Columbia."

Answered by AI

For what medical purposes is Ibuprofen most commonly prescribed?

"Inflammation of the mucous membranes, muscle spasms, and fever can all be treated with Ibuprofen."

Answered by AI

Are patients being actively recruited for participation in this clinical trial?

"Yes, the clinical trial is presently enrolling 100 patients from 8 different locations. The information was initially posted on 1/10/2022 and was last edited on 1/3/2022."

Answered by AI

Could you provide some context for this trial by referencing similar studies?

"Ibuprofen has 46 studies underway with 11 of them in the last stage before approval. Although most trials are based in Pittsburgh, Pennsylvania, there are Ibuprofen clinical trials taking place at 93 different locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT
Dr. Souvik Mitra, MD MSc FRCPC 2022. "Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05011149.
~0 spots leftby Apr 2024
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