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Nonsteroidal Anti-inflammatory Drug (NSAID)
Acetaminophen + Ibuprofen for Patent Ductus Arteriosus
Phase 2
Recruiting
Led By Amish Jain, MD PhD
Research Sponsored by Mount Sinai Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Preterm infants born <27+0 weeks gestational age
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-10 days post treatment initiation
Awards & highlights
Study Summary
This trial is testing whether a combination of ibuprofen and acetaminophen is more effective than ibuprofen alone in treating patent ductus arteriosus, a common heart problem in premature babies.
Who is the study for?
This trial is for extremely premature infants (born before 27 weeks) with a heart condition called PDA, where the duct fails to close after birth. Infants must not have had previous PDA treatment, except for indomethacin used to prevent bleeding in the brain. They should also have normal kidney and liver function and an adequate platelet count.Check my eligibility
What is being tested?
The study tests if giving Ibuprofen together with IV Acetaminophen is more effective than Ibuprofen alone for treating PDA in very early-born babies. The goal is to see if this combination can improve outcomes by acting on different pathways that keep the duct open.See study design
What are the potential side effects?
Possible side effects include issues related to liver or kidney function, blood clotting problems due to low platelets, gastrointestinal disturbances like stomach pain or nausea, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My baby was born before 27 weeks of pregnancy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-10 days post treatment initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-10 days post treatment initiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite of pre-discharge mortality or any grade BPD
Secondary outcome measures
Duration (days) of invasive or non-invasive respiratory support
Further exposure to pharmacological PDA treatments
Mortality
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Combination TherapyExperimental Treatment2 Interventions
Intravenous or enteral ibuprofen, as decided by clinical team, in the standard clinical dose used in participating NICUs (typically, for neonates < 7 days old - 10 mg/kg/dose on day 1, 5 mg/kg/dose q24h on days 2 and 3; for neonates > 7 days old - 20 mg/kg/dose on day 1, 10 mg/kg/dose q24h on days 2 and 3) And study drug (intravenous acetaminophen 15 mg/kg/dose IV q6h for 3 days).
Group II: Standard Clinical Practice - MonotherapyPlacebo Group2 Interventions
Intravenous or enteral ibuprofen, as decided by clinical team, in the standard clinical dose used in participating NICUs (typically, for neonates < 7 days old - 10 mg/kg/dose on day 1, 5 mg/kg/dose q24h on days 2 and 3; for neonates > 7 days old - 20 mg/kg/dose on day 1, 10 mg/kg/dose q24h on days 2 and 3) And Placebo [(0.9% saline IV q6h for 3 days).
Find a Location
Who is running the clinical trial?
Mount Sinai Hospital, CanadaLead Sponsor
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67,298 Total Patients Enrolled
Sunnybrook Health Sciences CentreOTHER
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McMaster Children's HospitalOTHER
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17,015 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My baby was born before 27 weeks of pregnancy.I am set to start treatment with ibuprofen through IV or feeding tube.Your liver is not working well, as shown by high levels of a liver enzyme called ALT.Your platelet count is less than 50,000 per drop of blood.I have been treated for PDA with drugs, except for indomethacin used to prevent brain bleeding.I have a genetic or chromosomal abnormality.My kidneys are not working well, shown by low urine output or high creatinine.You have a certain heart condition called PDA with a large opening and blood flow that goes from the left side to the right side.
Research Study Groups:
This trial has the following groups:- Group 1: Combination Therapy
- Group 2: Standard Clinical Practice - Monotherapy
Awards:
This trial has 0 awards, including: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.
Is there an open opportunity for patients to enroll in this research?
"The information on clinicaltrials.gov reveals that this medical trial is not currently recruiting, even though it was initially posted November 1st 2022 and most recently updated October 24th 2022. Nevertheless, there are over two hundred sixty-nine other studies open for enrollment at present."
Answered by AI
Does the FDA recognize Ibuprofen 20 mg/mL oral suspension or Ibuprofen lysine 10 mg/mL injection solution (Neoprofen) as safe for use?
"Our evaluation yielded a score of 2 for the safety profile of Ibuprofen 20 mg/mL oral suspension or Ibuprofen lysine 10 mg/mL injection solution (Neoprofen). This is due to Phase 2 trial data, which indicates that while there are some preliminary studies showing safety, no efficacy has been demonstrated."
Answered by AI
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