NCT03367832 - 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)

Bickler SW, Rode H
Surgical services for children in developing countries. Bull World Health Organ. 2002;80(10):829-35. Epub 2002 Nov 28. Review.
LeBrun DG, Chackungal S, Chao TE, Knowlton LM, Linden AF, Notrica MR, Solis CV, McQueen KA
Prioritizing essential surgery and safe anesthesia for the Post-2015 Development Agenda: operative capacities of 78 district hospitals in 7 low- and middle-income countries. Surgery. 2014 Mar;155(3):365-73. doi: 10.1016/j.surg.2013.10.008. Epub 2013 Oct 11.

South African Paediatric Surgical Outcomes Study (SAPSOS) A South African National, Multi-centre Fourteen Day Evaluation of Patient Care and Clinical Outcomes for Paediatric Patients Undergoing Surgery

Details for clinical trial NCT03367832

Clinical trial NCT03367832 - References