Clinical trial NCT04393064: Fiberoptic Endoscopic Evaluation of Swallowing(FEES) in Infants Graduated From (NICU) Neonatal Intensive Care Unite
Official title: Fiberoptic Endoscopic Evaluation of Swallowing(FEES) in Infants Graduated From (NICU) Neonatal Intensive Care Unite
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fiberoptic Endoscope Evaluation of Swallowing in Infants(FEES)
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 75 preterm and 75 fullterm will be recruited in this study; all will be hemodynamically stable on discharge then doing FEES
Primary purpose: DIAGNOSTIC

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Fiberoptic endoscopic evaluation of swallowing (FEES)
timeFrame: baseline
Secondary outcomes:
measure: Other imaging procedures including X-ray (Chest & abdominal) , U/S(ultrasound) , CT(computer tomography) & ECHO(Echocardiography)
timeFrame: baseline
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Lamiaa Mohamed
Study officials:
affiliation: assistant professour
name: Dina Akmal, MD
role: STUDY_DIRECTOR
affiliation: assistant professour
name: Engy Tosson, MD
role: STUDY_DIRECTOR
affiliation: assistant professour
name: Ayaallah Shekhany, MD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
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.