Feeding and Swallowing Problems in Infants With Laryngomalacia

NCT05337475 | Completed DMC

• 1 other identifier: Soh-Med-22-04-23
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Feeding Disorders; Swallowing Disorder; Laryngomalacia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• The Functional Oral Intake Scale- Suckle Feeds and Transitional Feeds (FOIS-SFTF)

  2 years

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Infants up to 2 years old diagnosed with laryngomalacia.
• Full term infants.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospitals

Sohag, Sohag Governorate, 82524, Egypt

Location

MeSH Terms

Conditions

Feeding and Eating Disorders; Deglutition Disorders; Laryngomalacia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cartilage Diseases; Musculoskeletal Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 20, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: May 22, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

EG (1)