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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Fiberoptic Endoscope Evaluation of Swallowing in Infants(FEES)

Intervention / Treatment
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* Device: fiberoptic endoscopic evaluation of swallowing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: 75 preterm and 75 fullterm will be recruited in this study; all will be hemodynamically stable on discharge then doing FEES
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: full term and preterm<br>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<br>* 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 .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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