NCT04393064 - 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)

da Silva AP, Lubianca Neto JF, Santoro PP
Comparison between videofluoroscopy and endoscopic evaluation of swallowing for the diagnosis of dysphagia in children. Otolaryngol Head Neck Surg. 2010 Aug;143(2):204-9. doi: 10.1016/j.otohns.2010.03.027.
Dodrill P, Gosa MM
Pediatric Dysphagia: Physiology, Assessment, and Management. Ann Nutr Metab. 2015;66 Suppl 5:24-31. doi: 10.1159/000381372. Epub 2015 Jul 24. Review.
Sitton M, Arvedson J, Visotcky A, Braun N, Kerschner J, Tarima S, Brown D
Fiberoptic Endoscopic Evaluation of Swallowing in children: feeding outcomes related to diagnostic groups and endoscopic findings. Int J Pediatr Otorhinolaryngol. 2011 Aug;75(8):1024-31. doi: 10.1016/j.ijporl.2011.05.010. Epub 2011 Jun 12.
Willette S, Molinaro LH, Thompson DM, Schroeder JW Jr
Fiberoptic examination of swallowing in the breastfeeding infant. Laryngoscope. 2016 Jul;126(7):1681-6. doi: 10.1002/lary.25641. Epub 2015 Sep 15.

Fiberoptic Endoscopic Evaluation of Swallowing(FEES) in Infants Graduated From (NICU) Neonatal Intensive Care Unite

Clinical trial NCT04393064 - References