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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05337475
Other study ID # Soh-Med-22-04-23
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date April 22, 2024

Study information

Verified date December 2022
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Observational cross-sectional study Infants with laryngomalacia Feeding and swallowing assessment


Description:

Identification of swallowing and feeding disorders in infants with laryngomalacia. Identify if there is relation between severity of laryngomalacia and feeding and swallowing disorder.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date April 22, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Month to 24 Months
Eligibility Inclusion criteria: - Infants up to 2 years old diagnosed with laryngomalacia. - Full term infants. Exclusion criteria: - Infants with other possible causes of dysphagia e.g., craniofacial anomalies, BDMH and neurological affection secondary to birth trauma, hypoxic ischemic encephalopathy and other brain insults. - Infants who were lethargic and/or medically unstable and were generally unable to participate to protocol of assessment. - Premature infants.

Study Design


Locations

Country Name City State
Egypt Sohag University Hospitals Sohag ?????

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mansoura Early Feeding Skills Assessment (MEFSA) an 85-item observational measure of oral feeding skill. It will be used for assessing oral feeding through maturation of oral feeding skill. The MEFSA includes 3 main sections; pre-feeding, during feeding and post-feeding sections. The "during feeding" section, "Oral Feeding Maintenance" will be used in this study which supports infant based feeding that give the infant opportunity to communicate and express stress signals that must be respected. It proposed to observe the infant from moment to moment during feeding. This section composed of 30 items to assess infant abilities to (a) remain engaged in feeding, (b) organize oral-motor skills, (c) maintain physiologic stability and (d) coordinate SSB. 2 years
Primary Fibreoptic Endoscopic Evaluation of swallowing (FEES) FEES will be done with presentations of food and/or milk consistency (Secretions, thin and thick fluids, puree and/or solids) to obtain multiple trials of each texture. Infants who are fed only milk, FEES will be performed either with bottle-feeding or 5ml syringe (without needle) with the milk.
Each infant will be fed by his or her typical caregiver or by the nurse. The feeding protocol began by presenting the infants with the bottle and/or nipple. If no aspiration occurred on the initial swallows, then the infant will be allowed to suck on the bottle until there was a change in swallowing function, 60 ml was finished, or the infant refused to suck.
2 years
Secondary The Functional Oral Intake Scale- Suckle Feeds and Transitional Feeds (FOIS-SFTF) score (1) stand for nothing by mouth, score (2) Tube dependent, with minimal attempts at liquids or food, score (3) Tube dependent, with consistent intake of liquids or food, score (4) Total oral diet, but requiring special preparation of liquids (ie, thickened liquids) +/- compensations, score (4.5) Total oral diet, but requiring special preparation of solids (eg, foods of different texture and/or liquid supplements) +/- compensations, score (5) Total oral diet, without special preparation (ie, regular thin fluids, foods of same texture as peers, and no additional liquid supplements), but with compensations, score (6) Total oral diet, with no restrictions 2 years
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