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

NCT ID: NCT04393064

Last Updated: 2020-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2020-12-01

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

Conditions

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Fiberoptic Endoscope Evaluation of Swallowing in Infants(FEES)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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full term and preterm

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

Group Type OTHER

fiberoptic endoscopic evaluation of swallowing

Intervention Type 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

.

Interventions

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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

.

Intervention Type DEVICE

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
Minimum Eligible Age

1 Day

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Lamiaa Mohamed Abdel Motaleb

Neonatal specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dina Akmal, MD

Role: STUDY_DIRECTOR

assistant professour

Engy Tosson, MD

Role: STUDY_DIRECTOR

assistant professour

Ayaallah Shekhany, MD

Role: STUDY_DIRECTOR

assistant professour

Locations

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Lamiaa Mohamed

Giza, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 26372024 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20647120 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21663978 (View on PubMed)

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.

Reference Type RESULT
PMID: 26226994 (View on PubMed)

Other Identifiers

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FEES IN INFANTS

Identifier Type: -

Identifier Source: org_study_id

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