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Acetaminophen + Ibuprofen for Patent Ductus Arteriosus
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Combination Therapy
- Group 2: Standard Clinical Practice - Monotherapy
- 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
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."
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."
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