Feeding and Swallowing Problems in Infants With Laryngomalacia

Completed

• Conditions: Feeding Disorders; Laryngomalacia; Swallowing Disorder

• Registration Number: NCT05337475
• Lead Sponsor: Sohag University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-20
• Primary Completion: 2024-04-01
• Study Completion: 2024-05-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-18
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mansoura Early Feeding Skills Assessment (MEFSA)	2 years	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.
Fibreoptic Endoscopic Evaluation of swallowing (FEES)	2 years	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.

Secondary Outcome Measures

Name	Time	Method
The Functional Oral Intake Scale- Suckle Feeds and Transitional Feeds (FOIS-SFTF)	2 years	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

Trial Locations

Locations (1)

Sohag University Hospitals; 🇪🇬 Sohag, سوهاج, Egypt