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

Fiberoptic Endoscope Evaluation of Swallowing in Infants(FEES) Clinical Trial

— FEES  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04393064
• Other study ID #: FEES IN INFANTS
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: July 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Based on study showing the ability of using FEES in infant in NICU; so the aim of this study to screen the newborns graduated from NICU using clinical bed side evaluation as well as flexible endoscopic assessment of swallowing to identify the ones suffering from oropharyngeal and / or esophageal dysphagia as well as newborns at risk for aspiration &aspiration pneumonia to tailor or identify appropriate feeding plan for those high risk popularities and support them

Description:

• Population study& disease condition Newborns that are discharged from NICU and are hemodynamically stable.

• Interventions The following study will be conducted in neonatal intensive care unit of Kasr alany and Abu EI-Rish hospital, also conducted in Phoniatrics Outpatient of Kasr alany, Cairo university This study will recruit 75 preterm and 75 fullterm will be recruited in this study; all will be hemodynamically stable on discharge

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• Item

• Neonates who discharged from NICU as they are hemodynamic stable

Exclusion Criteria:

• Item

• Neonates with congenital anomalies that interfere with the introduction or the procedure of FEES as nasal deformities, choanal atresia, cleft lip and cleft palate.

• Neonates have liver disease and/ or bleeding tendency

Related Conditions & MeSH terms

• Fiberoptic Endoscope Evaluation of Swallowing in Infants(FEES)

Intervention

Device:
• fiberoptic endoscopic evaluation of swallowing
intreventions name :-Fiberoptic endoscopic evaluation of swallowing(FEES) will be performed on all infants enrolled in this study. interventions type: flexible nasopharyngeal laryngoscope 3,5 mm in size with portable camera & light source & video recording system will be used. Procedure will be done without anesthesia .

Locations

Country	Name	City	State
Egypt	Lamiaa Mohamed	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fiberoptic endoscopic evaluation of swallowing (FEES)	to identify the ones suffering from oropharyngeal and / or esophageal dysphagia as well as newborns at risk for aspiration &aspiration pneumonia by FEES to tailor or identify appropriate feeding plan for those high risk popularities and support them	baseline
Secondary	Other imaging procedures including X-ray (Chest & abdominal) , U/S(ultrasound) , CT(computer tomography) & ECHO(Echocardiography)	for any disorder affecting swallowing	baseline