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

July 17, 2020 updated by: Lamiaa Mohamed Abdel Motaleb, Cairo University
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Lamiaa Mohamed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: full term and preterm
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

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

.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fiberoptic endoscopic evaluation of swallowing (FEES)
Time Frame: 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
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)
Time Frame: baseline
for any disorder affecting swallowing
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Dina Akmal, MD, assistant professour
  • Study Director: Engy Tosson, MD, assistant professour
  • Study Director: Ayaallah Shekhany, MD, assistant professour

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

May 15, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 17, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • FEES IN INFANTS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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