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Acetaminophen + Ibuprofen for Patent Ductus Arteriosus in Extremely Premature Infants
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.
- Patent Ductus Arteriosus
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
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Who is running the clinical trial?
- You have not been treated with any medication for a certain condition called PDA, except for using indomethacin to prevent bleeding in the brain.Babies born before 27 weeks of pregnancy.Abnormalities in the chromosomesYou have a certain type of heart problem called a PDA that is larger than 1.5 millimeters and is causing a specific type of blood flow in the heart.You are scheduled to receive your first treatment with ibuprofen through a vein or through your stomach, as decided by your medical team.You have fewer than 50,000 platelets in a small amount of blood.Your kidneys are not working well, as shown by low urine output or high levels of creatinine in your blood.Your liver function is not normal, with high levels of ALT in your blood.
- 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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