Feeding and Swallowing Problems in Infants With Laryngomalacia

Swallowing Disorder Clinical Trial

Official title:

Feeding and Swallowing Problems in Infants With Laryngomalacia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05337475
• Other study ID #: Soh-Med-22-04-23
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Disease
• Feeding and Eating Disorders
• Feeding Disorders
• Laryngomalacia
• Swallowing Disorder

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