Feeding and Swallowing Problems in Infants With Laryngomalacia

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

Study Overview

• Status: Recruiting
• Conditions: Swallowing Disorder; Feeding Disorders; Laryngomalacia

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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Egypt
  • سوهاج
    • Sohag, سوهاج, Egypt, 82524
      • Recruiting
      • Sohag University hospitals
      • Contact: Amal F Sayed, Msc.; Phone Number: 00201007424035; Email: amal.mahmoud@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Infants with suspected laryngomalacia referred to phoniatrics unit, Sohag University Hospitals.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 22, 2024

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Congenital Abnormalities; Gastrointestinal Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Musculoskeletal Abnormalities; Laryngeal Diseases; Cartilage Diseases; Disease; Feeding and Eating Disorders; Deglutition Disorders; Laryngomalacia
• Other Study ID Numbers: Soh-Med-22-04-23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No