Fiberoptic Endoscope Evaluation of Swallowing in Infants(FEES)FEESNCT04393064
Fiberoptic Endoscopic Evaluation of Swallowing(FEES) in Infants Graduated From (NICU) Neonatal Intensive Care Unite
A study testing fiberoptic endoscopic evaluation of swallowing in people with Fiberoptic Endoscope Evaluation of Swallowing in Infants(FEES), run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Fiberoptic Endoscope Evaluation of Swallowing in Infants(FEES)
- What is being tested?
- fiberoptic endoscopic evaluation of swallowing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2017to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Item
- Neonates who discharged from NICU as they are hemodynamic stable
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- fiberoptic endoscopic evaluation of swallowing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fiberoptic endoscopic evaluation of swallowingDevice
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
.
| Study group | Role | What they receive |
|---|---|---|
| full term and preterm | Other | 75 preterm and 75 fullterm will be recruited in this study; all will be hemodynamically stable on discharge doing FEES Receives: Device: fiberoptic endoscopic evaluation of swallowing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (1)
Other imaging procedures including X-ray (Chest & abdominal) , U/S(ultrasound) , CT(computer tomography) & ECHO(Echocardiography)
for any disorder affecting swallowing
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Dec 2017
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fiberoptic Endoscope Evaluation of Swallowing in Infants(FEES)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamiaa Mohamed Abdel Motaleb, Cairo University
- Investigators
- Dina Akmal, MD, Study director, assistant professourEngy Tosson, MD, Study director, assistant professourAyaallah Shekhany, MD, Study director, assistant professour
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393064
- Sponsor's protocol ID
- FEES IN INFANTS
- Acronym
- FEES
- Status last verified
- Jul 2020
- First submitted
- 9 Apr 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26372024da 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.
PubMed 20647120Sitton 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.
PubMed 21663978Dodrill 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.
PubMed 26226994
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fiberoptic Endoscopic Evaluation of Swallowing(FEES) in Infants Graduated From (NICU) Neonatal Intensive Care Unite
- ClinicalTrials.gov ID
- NCT04393064
- Acronym / sponsor ID
- FEES / FEES IN INFANTS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 75 preterm and 75 fullterm will be recruited in this study; all will be hemodynamically stable on discharge then doing FEES
| Arm | Type | Receives |
|---|---|---|
| full term and preterm | Other | Device: fiberoptic endoscopic evaluation of swallowing75 preterm and 75 fullterm will be recruited in this study; all will be hemodynamically stable on discharge doing FEES |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Item
Key exclusion criteria (3 listed)
- Item
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fiberoptic endoscopic evaluation of swallowingintreventions 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 . | Device | full term and preterm |
Primary outcome
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
1 secondary outcome
Other imaging procedures including X-ray (Chest & abdominal) , U/S(ultrasound) , CT(computer tomography) & ECHO(Echocardiography)
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Background: PubMed 26372024Willette 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.
- Background: PubMed 20647120da 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.
- Background: PubMed 21663978Sitton 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.
- Results publication: PubMed 26226994Dodrill 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dina Akmal, MD study director
assistant professour
Engy Tosson, MD study director
assistant professour
Ayaallah Shekhany, MD study director
assistant professour
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fiberoptic endoscopic evaluation of swallowing in people with Fiberoptic Endoscope Evaluation of Swallowing in Infants(FEES), run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fiberoptic endoscopic evaluation of swallowing (FEES) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04393064, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.