NCT05394454 - 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)

Altuntas N, Tayfur AC, Kocak M, Razi HC, Akkurt S
Midstream clean-catch urine collection in newborns: a randomized controlled study. Eur J Pediatr. 2015 May;174(5):577-82. doi: 10.1007/s00431-014-2434-z. Epub 2014 Oct 17.
Herreros Fernández ML, González Merino N, Tagarro García A, Pérez Seoane B, de la Serna Martínez M, Contreras Abad MT, García-Pose A
A new technique for fast and safe collection of urine in newborns. Arch Dis Child. 2013 Jan;98(1):27-9. doi: 10.1136/archdischild-2012-301872. Epub 2012 Nov 21.
Kaufman J
How to… collect urine samples from young children. Arch Dis Child Educ Pract Ed. 2020 Jun;105(3):164-171. doi: 10.1136/archdischild-2019-317237. Epub 2019 Aug 23.
Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S
The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
Morello W, La Scola C, Alberici I, Montini G
Acute pyelonephritis in children. Pediatr Nephrol. 2016 Aug;31(8):1253-65. doi: 10.1007/s00467-015-3168-5. Epub 2015 Aug 4. Review.
Senayli Y, Özkan F, Senayli A
Evaluation of postoperative pain in Turkish Translation. Turkish Clinics Journal of Anesthesiology Reanimation. 2006; 4(1): 1-4.
Tran A, Fortier C, Giovannini-Chami L, Demonchy D, Caci H, Desmontils J, Montaudie-Dumas I, Bensaïd R, Haas H, Berard E
Evaluation of the Bladder Stimulation Technique to Collect Midstream Urine in Infants in a Pediatric Emergency Department. PLoS One. 2016 Mar 31;11(3):e0152598. doi: 10.1371/journal.pone.0152598. eCollection 2016.

The Effect of Non-invasive Bladder Stimulation Technique on Collecting Urine Specimen in Infants Under One Year Old: Randomized Controlled Trial

Details for clinical trial NCT05394454

Clinical trial NCT05394454 - References