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

NCT04393064 | Unknown DMC

• 1 other identifier: FEES IN INFANTS
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Fiberoptic Endoscope Evaluation of Swallowing in Infants(FEES)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Other imaging procedures including X-ray (Chest & abdominal) , U/S(ultrasound) , CT(computer tomography) & ECHO(Echocardiography)

  baseline

Study Arms (1)

full term and preterm

OTHER

75 preterm and 75 fullterm will be recruited in this study; all will be hemodynamically stable on discharge doing FEES

Device: fiberoptic endoscopic evaluation of swallowing

Interventions

fiberoptic endoscopic evaluation of swallowing DEVICE

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 .

full term and preterm

Eligibility Criteria

• Age: 1 Day - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Item
• Neonates who discharged from NICU as they are hemodynamic stable

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Lamiaa Mohamed

Giza, Egypt

Location

Related Publications (4)

• 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.

  PMID: 26372024 BACKGROUND

• 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.

  PMID: 20647120 BACKGROUND

• 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.

  PMID: 21663978 BACKGROUND

• 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.

  PMID: 26226994 RESULT

Study Officials

• Dina Akmal, MD

  assistant professour

  STUDY DIRECTOR

• Engy Tosson, MD

  assistant professour

  STUDY DIRECTOR

• Ayaallah Shekhany, MD

  assistant professour

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatal specialist

Model Details: 75 preterm and 75 fullterm will be recruited in this study; all will be hemodynamically stable on discharge then doing FEES

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: May 19, 2020
• Study Start: December 1, 2017
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)