NCT06256211 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Chiruvolu A, Jaleel MA
Therapeutic management of patent ductus arteriosus. Early Hum Dev. 2009 Mar;85(3):151-5. doi: 10.1016/j.earlhumdev.2008.12.007. Epub 2009 Feb 14.
Sivanandan S, Agarwal R
Pharmacological Closure of Patent Ductus Arteriosus: Selecting the Agent and Route of Administration. Paediatr Drugs. 2016 Apr;18(2):123-38. doi: 10.1007/s40272-016-0165-5.

Assessment of Therapeutic Effect of Rectal Vs. Intravenous Paracetamol in The Treatment of Patent Ductus Arteriosus (PDA) in Neonates

Clinical trial NCT06256211 - References