NCT06134141 - 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)

Backes CH, Cheatham SL, Deyo GM, Leopold S, Ball MK, Smith CV, Garg V, Holzer RJ, Cheatham JP, Berman DP
Percutaneous Patent Ductus Arteriosus (PDA) Closure in Very Preterm Infants: Feasibility and Complications. J Am Heart Assoc. 2016 Feb 12;5(2):e002923. doi: 10.1161/JAHA.115.002923.
Crystal MA, Ing FF
Pediatric interventional cardiology: 2009. Curr Opin Pediatr. 2010 Oct;22(5):567-72. doi: 10.1097/MOP.0b013e32833e1328.
Moustafa GA, Kolokythas A, Charitakis K, Avgerinos DV
Therapeutic Utilities of Pediatric Cardiac Catheterization. Curr Cardiol Rev. 2016;12(4):258-269. doi: 10.2174/1573403x12666160301121253.

The Outcome of Interventional Cardiac Catheterization In Pediatric Cardiology Unit, Assiut University Heart Hospital

Clinical trial NCT06134141 - References