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

Not Applicable

• Conditions: Fiberoptic Endoscope Evaluation of Swallowing in Infants(FEES)
• Interventions: Device: fiberoptic endoscopic evaluation of swallowing

• Registration Number: NCT04393064
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-05-15
• Study First Posted: 2020-05-19
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-21
• Primary Completion: 2020-10-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
full term and preterm	fiberoptic endoscopic evaluation of swallowing	75 preterm and 75 fullterm will be recruited in this study; all will be hemodynamically stable on discharge doing FEES

Primary Outcome Measures

Name	Time	Method
Fiberoptic endoscopic evaluation of swallowing (FEES)	baseline	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

Secondary Outcome Measures

Name	Time	Method
Other imaging procedures including X-ray (Chest & abdominal) , U/S(ultrasound) , CT(computer tomography) & ECHO(Echocardiography)	baseline	for any disorder affecting swallowing

Trial Locations

Locations (1)

Lamiaa Mohamed; 🇪🇬 Giza, Egypt